Additional artemisinin and berberine compositions and methods of making

ABSTRACT

An Alternative ACT composition consisting of natural botanical active ingredients, all of which are GRAS (generally regarded as safe by the FDA). The novel Artemisinin Combination Therapy (ACT) consists of artemisinin and its derivatives, berberine, capsaicin, and papaya extract. The four active substances mixed with various selected excipient compounds to form a single pill, tablet or capsule for the treatment and prevention of chikungunya.

CROSS REFERENCE TO RELATED APPLICATIONS

The application is a Continuation-In-Part of U.S. patent applicationSer. No. 14/614,946 filed Feb. 5, 2015, now U.S. Pat. No. 9,186,331,which is a Divisional patent application of U.S. patent application Ser.No. 13/660,553 filed Oct. 25, 2012, now U.S. Pat. No. 9,011,892, whichclaims the benefit of priority to U.S. Provisional Patent ApplicationSer. No. 61/550,969 filed Oct. 25, 2012. The entire disclosure of eachof the applications listed in this paragraph are incorporated herein byspecific reference thereto.

FIELD OF INVENTION

The present invention relates generally to novel therapeuticcompositions, and more specifically to natural botanical ingredients andcompositions and methods of making and combining artemisinin, berberine,capsaicin, and papaya extract to produce an Alternative ACT thatdelivers active therapeutic treatment and prevention of diseases andinfections caused by bacteria, viruses and parasites, and morespecifically for the treatment of chikungunya.

BACKGROUND AND PRIOR ART

There is renewed and continuing focus on treatments for infections anddiseases that include, but are not limited to, malaria, yellow fever,dengue fever, caused by mosquito bites; dysentery caused by bacteria andparasites; Lyme disease and babesiosis, caused by ticks. Often there isnot a satisfactory prophylaxis treatment or, in the case of malaria,antimalarial treatments with quinine and other synthetic drugs haveresulted in drug resistant strains of malaria which can result in severeadverse outcomes, such as increased mortality, morbidity and medicalcare costs for patients suffering from common infections, oncetreatable.

Malaria has four types that can infect humans. Of the four types ofmalaria, the most life-threatening type is Plasmodium falciparum, knownto be the most lethal form of the plasmodium parasite, causing thegreatest number of malaria infections and deaths. Often called junglefever or swamp fever, malaria is characterized by cycles of chills,fever, and sweating, caused by the parasitic infection of red bloodcells by the protozoan parasite Plasmodium which is transmitted by thebite of an infected vector for human malarial parasite, a femaleAnopheles mosquito.

The other three types of malaria which include vivax, malariae, andovale, are generally less serious and are not life-threatening but needto be treated, as their untreated progress can cause a host of healthproblems.

To date, there is no absolute cure for malaria. Early diagnosis can leadto alleviation of malaria, and prevention remains more effective thantreatment. Anti-malarial medication can and should be taken preventivelyby native populations and travelers in affected regions, such as thetropics and sub-Saharan Africa.

Anti-malarial drugs are available that treat malaria effectively, butthere remains the problem of incorrect dosages by self-administeringpatients, inaccurate combining of ACTs (artemisinin combination therapy)which leads to potential mono-therapeutic treatment with artemisinin andresults in highly-resistant strains of malaria, and the lack of adequatedelivery systems for children, all of which causes the pattern ofrepetitive disease to continue.

Another problem is that many of the current ACTs contain some form ofquinine, which has long been determined to have serious side effects,especially in children.

Yellow fever is a viral infection and is carried by female mosquitoes oftwo species (Aedes and Haemogogus). The “yellow” in the name refers tothe jaundice that affects some patients. Mosquitoes pass yellow fever tohumans through a small amount of saliva when they bite. The species ofmosquito that carry yellow fever are native to sub-Saharan Africa andSouth America.

Yellow fever can cause flu-like symptoms, fever, headache, muscle pain,chills, nausea, vomiting, yellowing of both the skin and the whites ofthe eyes, and can cause death. Vaccination is the best way to preventyellow fever. However, people with compromised immune systems, elderlyindividuals, and women who may be pregnant or nursing should not receivethe vaccine.

There is presently no specific treatment for yellow fever, onlysupportive care to treat dehydration and fever. Associated bacterialinfections can be treated with antibiotics. Supportive care may improveoutcomes for seriously ill patients, but it is rarely available inpoorer areas.

Prompt detection of yellow fever and rapid response through emergencyvaccination campaigns are essential for controlling outbreaks. However,underreporting is a concern and the true number of cases is estimated tobe 10 to 250 times what is now being reported. The World HealthOrganization (WHO) recommends that every at-risk country have at leastone national laboratory where basic yellow fever blood tests can beperformed. Due to the severe threat of epidemic, and the resultant lossof life on a large scale, one confirmed case of yellow fever in anunvaccinated population should be considered an outbreak, and aconfirmed case in any context must be fully investigated, particularlyin any area where most of the population has been vaccinated.

Dengue fever is a viral infection transmitted by the bite of an infectedmosquito. Mosquitoes can pick up the dengue virus then carry the virusin their own blood, and spread it when they bite humans. The Center forDisease Control and Prevention reports that with more than one-third ofthe world's population living in areas at risk for transmission, dengueinfection is a leading cause of illness and death in the tropics andsubtropics. As many as 100 million people are infected yearly. Thesymptoms of dengue fever resemble symptoms of influenza (flu) and caninclude fever, severe headache, severe pain behind the eyes, joint pain,muscle and/or bone pain, rash and the like. See for example, DenguePage, CDC Centers for Disease Control and Prevention, CDC 24/7:http://www.cdc.gov/dengue, Sep. 27, 2012.

Dengue hemorrhagic fever (DHR) is characterized by a fever that lastsfrom 2 to 7 days, with general signs and symptoms consistent with denguefever. When the fever declines, hemorrhagic manifestations and lowplatelet count accompanies other symptoms. There is no specificmedication for treatment of a dengue infection. Analgesics, such asacetaminophen, are recommended for pain relief. Aspirin andaspirin-containing drugs should not be taken because aspirin wouldincrease the risk for severe bleeding and hemorrhage.

Dysentery is an intestinal inflammation, especially in the colon, thatcan lead to severe diarrhea with mucus or blood in the feces. There aretwo main types of dysentery. Bacillary dysentery is caused by Shigella,a bacterium that secretes substances known as cytotoxins, which kill anddamage intestinal tissue on contact. Amoebic dysentery (amoebiasis) iscaused by Entamoeba histolytica, a type of amoeba that reaches the largeintestine after entering orally, through ingestion of contaminated foodor water, or oral contact with contaminated objects or hands.

Other symptoms that accompany frequent watery stools include abdominalpain, fever and chills, nausea and vomiting. Treatment can includerehydration therapy, administration of antibiotics and amoebicidaldrugs. Prevention can include good hygiene, taking measures to reducerisk of infection by regularly washing hands after going to the toiletand before preparing or eating food, drinking water from reliablesources and using purified water to clean your teeth.

Lyme disease is a bacterial infection transmitted by a tick. Lymedisease was first recognized around 1975, after an unusually largenumber of children were being diagnosed with juvenile rheumatoidarthritis in Lyme, Conn. (USA) and two neighboring towns. Tiny deerticks infected with the bacterium Borrelia burgdorferi, were found to beresponsible for the outbreak of arthritis in Lyme.

Not every bite from a deer tick causes Lyme disease. It is more likelyto occur if the tick stays attached to an individual's skin for 36 hoursor more. Cases have been reported in nearly all states, and the diseaseis also on the rise in large areas of Asia and Europe.

Lyme disease can be transmitted through a bite from ticks infected withBorrelia burgdorferi. In the early stages of Lyme disease, there areflu-like symptoms that can include a stiff neck, chills, fever, swollenlymph nodes, headaches, fatigue, muscle aches and joint pain. There mayalso be a large, expanding skin rash around the area of the tick bite.Treatment includes antibiotics, such as doxycycline or amoxicillin. Thesooner such therapy is begun following infection, the quicker and morecomplete the recovery. Prolonged antibiotic use may have serious sideeffects.

In the late stage of the disease, in addition to causing arthritis, Lymedisease can also cause heart, brain and nerve problems.

Babesiosis is a malaria-like illness caused by a protozoan parasite(Babesia microti in the United States and other members of the Babesiagenus in Europe) that invades red blood cells, and is primarilytransmitted by the deer tick Ixodes scapularis and possibly otherrelated Ixodid ticks.

In Europe, reported fatal cases of babesiosis have occurred mostly inpatients whose spleens have been removed, rendering them more vulnerableto infection. The offending parasites in these cases have been either B.divergens or B. major, to which humans (with spleens intact) are thoughtto be naturally resistant. In the U.S., reported fatal cases haveoccurred in patients both with and without spleens; B. microti may be amore virulent agent to which humans are not naturally resistant.However, while many in the U.S. who are exposed to the parasite dosuffer severe symptoms, fatalities generally occur in elderly patientswith compromised immune systems. The heightened risk is in misdiagnosis;since the illness presents like a severe case of influenza, many ofthose infected do not seek treatment. Unlike Lyme disease, babesiosisdoes not always present with a tell-tale rash, making it more difficultto suspect. There is a 20% mortality rate for those who are severelyinfected and do not receive treatment.

Babesiosis cases have been on the rise in the U.S. since the first humancase was recognized on Nantucket Island (off the coast of Massachusetts)in 1968. Due to climate changes, the expanding domain of ticks thatcarry the parasite, and greater human and pet interaction with areascontaining the ticks, babesiosis now presents a real danger to thoseresiding and venturing into areas of contamination. The deer(black-legged) tick in the Northeast and upper Midwest, and the Westernblack-legged tick on the Pacific coast are the primary carriers. Amajority of reported cases occur during the summer months along theimmediate coast and off-shore islands of the Northeast, but the tickshave now migrated to areas of the Mid-Atlantic and further South.

The symptoms of babesiosis normally begin about a week after a tick bitewith a gradual onset of malaise, anorexia and fatigue. This is followedseveral days later by high fever, drenching sweats, muscle pain andheadaches. As with malaria, these symptoms can continue over aprotracted period or can abate, then recur. Diagnosis can involveexamining blood smears and recognizing the characteristic “ring” formtaken by the Babesia parasite within the red blood cells of the patient.Recommended treatment has included a seven-day course of oral quinineplus clindamycin under the careful supervision of a physician. Both ofthese remedies have been used on malaria as well, now to be supplantedby the more preferable ACTs. Since quinine has known negative sideeffects, and can be harmful to both children and pregnant women, anatural ACT with no known side effects should be the preferred course oftreatment. Without it, fatigue, malaise and a low grade fever maypersist for weeks or months after quinine and clindamycin treatment hasbeen completed.

Progressive multifocal leukoencephalopathy (PML) is a disease of thewhite matter of the brain, caused by a virus infection that targetscells that make myelin (the material that insulates neurons). PML is ademyelinating disease, in which the myelin sheath covering the axons ofnerve cells is gradually destroyed, impairing the transmission of nerveimpulses. It affects the subcortical white matter, particularly that ofthe parietal and occipital lobes. PML is similar to anotherdemyelinating disease, multiple sclerosis, but progresses much morequickly.

A certain strain of polyomavirus (referred to as John-Cunningham Virus,JCV) is carried by a majority of people and is harmless except amongthose with lowered immune defenses. It seems that by lowering the immunereaction, the JCV virus is reactivated and is causing demyelinizationleading to PML. The PML disease is rare and occurs in patientsundergoing chronic corticosteroid or immunosuppressive therapy for organtransplant, or individuals with cancer (such as Hodgkin's disease orlymphoma). Individuals with autoimmune conditions such as multiplesclerosis, rheumatoid arthritis, and systemic lupus erythematosis (someof whom are treated with biological therapies that allow JCVreactivation) are at risk for PML as well.

PML is most common among individuals with human immunodeficiency virus(HIV-1) infection; as well as acquired immune deficiency syndrome(AIDS). Studies estimate that prior to effective antiretroviral therapy,as many as 5 percent of persons infected with HIV-1 eventually developPML that is an AIDS-defining illness. However, current HIV therapy usingantiretroviral drugs (ART), which effectively restores immune systemfunction, allows as many as half of all HIV-PML patients to survive,although they may sometimes have an inflammatory reaction in the regionsof the brain affected by PML A diagnosis of PML can be made followingbrain biopsy or by combining observations of a progressive course of thedisease, consistent white matter lesions visible on a magnetic resonanceimaging (MRI) scan, and the detection of the JCV in spinal fluid.

Symptoms can include weakness or paralysis, vision loss, impairedspeech, and cognitive deterioration, the most prominent symptoms caninclude clumsiness; progressive weakness; and visual, speech, andpersonality changes. In addition, the lesions affecting the parietal andoccipital lobes can lead to a phenomenon known as alien hand syndrome.The symptoms of PML are diverse, since they are related to the locationand amount of damage in the brain, and may evolve over the course ofseveral weeks to months. The progression of deficits leads tolife-threatening disability and (frequently) death.

PML can be diagnosed by testing for JCV DNA (deoxyribonucleic acid) incerebrospinal fluid or in a brain biopsy specimen. Characteristicevidence of the damage caused by PML in the brain can also be detectedon magnetic resonance imaging (MRI) images, which classically showmultifocal nonenhancing lesions without mass effect. The most commonarea of involvement is the cortical white matter, but the brainstem andcerebellum may also be involved.

There is no known cure for PML. In some cases, the disease slows orstops if the patient's immune system improves; some AIDS patients withPML have been able to survive for several years, with the advent ofhighly active antiretroviral therapy (HAART). AIDS patients who startHAART after being diagnosed with PML tend to have a slightly longersurvival time than patients who were already on HAART and then developPML. A rare complication of effective HAART is immune reconstitutioninflammatory syndrome (IRIS), in which increased immune system activityactually increases the damage caused by the infection; although IRIS isoften manageable with other types of drugs, it is extremely dangerous ifit occurs in PML.

Other antiviral agents that have been studied as possible treatments forPML include cidofovir and interleukin-2, but this research is stillpreliminary. Cytarabine (also known as ARA-C), a chemotherapy drug usedto treat certain cancers, has been prescribed on an experimental basisfor a small number of non-AIDS PML patients. It is reported to havestabilized the neurological condition of a minority of these patients.One patient regained some cognitive function lost as a result of PML.

In June 2010, the first case report appeared of a PML patient beingsuccessfully treated with mefloquine. Mefloquine is an antimalarial drugthat can also act against the JCV. Administration of mefloquine seemedto eliminate the virus from the patient's body and prevented furtherneurological deterioration. It is our thought and hope, that with astudy conducted by the H. Lee Moffitt Cancer Center & Research Institutein Tampa Fla. using our ACT, which is devoid of the potentially damagingquinine and its derivatives, but is similar in action to mefloquineagainst malaria, may eventually prove to be an effective agent againstthe JCV, and subsequently lead to the successful safe treatment of PMLpatients. See for example, T E Gofton, A Al-Khotani, B O'Farrell, et al.Mefloquine in the treatment of progressive multifocalleukoencephalopathy. Journal Neurolology and Neurosurgery Psychiatry(2010). 82(4):452-5

Helicobacter pylori (HP) was first discovered in the stomachs ofpatients with gastritis and stomach ulcers by Dr Barry J. Marshall andDr J. Robin Warren, both of Australia. In 1982, conventional thinkingheld that bacteria could not live in the human stomach, due to the highlevels of acid present there, similar in strength to the acid found inan auto battery. Marshall and Warren altered the course of medicine withtheir discovery and for that, were awarded the 2005 Nobel Prize forMedicine and Physiology.

HP is a corkscrew-shaped, Gram-negative bacterium which is present inthe stomach lining of approximately 3 billion people worldwide, and isthe most common bacterial infection found in humans. Many of thosecarrying the bacterium have few or no symptoms, with the exception ofinflammation of the stomach lining, a condition which is called“gastritis.” Gastritis is the underlying condition which can eventuallycause ulcers and other digestive ailments. An HP infection maintainedfor 20-30 years can lead to cancer of the stomach. For this reason, theWorld Health Organization's International Agency for Research intoCancer has classified HP as a “Class I Carcinogen,” likening its dangerto the digestive system to that of cigarette smoking to the lungs andrespiratory tract.

The diseases are associated with HP can include duodenal ulcers, gastric(stomach) ulcers, stomach cancer, and non-ulcer dyspepsia. Diagnostictesting for HP can include breath tests, blood tests, endoscopies, andbiopsies. Common treatment for HP can be heavy dosing of antibiotics,given in combinations of two to four substances, commonly through aProton Pump Inhibitor. The treatment can be expensive, debilitating, andunsuccessful. Since HP has developed resistance to many commonly usedantibiotics, new treatments must be sought out and identified.

Artemisinin Combination Therapy (ACT) has been an alternative treatmentwhich shows great promise in its ability to act as a broad-basedantibiotic and anti-parasitic, especially when dealing with infectionsthat are rising through contamination by fecal matter, as HP is known tobe. ACTs are less debilitating for the patient, and have no known sideeffects as many of the currently prescribed antibiotics have. See forexample, Goswami S, B. R. (Epub 2012 Jun. 11). Anti-Helicobacter pyloripotential of artemisinin and its derivatives. Antimicrobial Agents andChemotherapy., 56(9):4594-607.

Colitis is a disease caused by inflammation of the large intestine,leading to symptoms which can include frequent diarrhea. Diarrhealdiseases are among the leading causes of morbidity and mortality inchildren worldwide, causing 1 billion episodes of illness and 3-5million deaths annually. In the United States, approximately 20-35million episodes of diarrhea occur each year in the 16.5 millionchildren who are younger than 5 years, resulting in 300-400 deaths.

Inflammatory bowel disease (IBD) is a generic term used to describeidiopathic disorders that are associated with gastrointestinal (GI)inflammation which can include Crohn's disease (CD), Ulcerative colitis(UC), and Indeterminate colitis. Colitis can have many different causes,which can include infections, including those caused by a virus,parasite, and food poisoning due to bacteria, inflammatory disorders(ulcerative colitis and Crohn's disease), lack of blood flow (includingischemic colitis and HSP), past radiation to the large intestine,Necrotizing enterocolitis (NEC), Allergic colitis, Pseudomembranouscolitis, and Colitis secondary to immune deficiency disorder. IBDsymptoms can include abdominal pain and bloating that is intermittentand unpredictable, bloody stools, chills, constant urge to have a bowelmovement, dehydration, frequent diarrhea, and persistent fever.

The onset of IBD commonly can occur during adolescence and youngadulthood. The risk of IBD in family members of an affected individualis approximately 7-22%; a child's risk of acquiring the disease is up to60%, and this risk is higher if both parents have the disease. Theprevalence of UC in the United States is 100-200 per 100,000 population.The incidence of CD is approximately 3-4 per 100,000 population, and theprevalence is approximately 30-100 per 100,000 population.

NEC is a disease of newborns, with low- and very low-birth-weightpreterm infants being particularly susceptible. NEC affectsapproximately 1-5% of patients admitted to neonatal intensive care units(ICUs) and may occur in approximately 2-5% of infants with birth weightslower than 1500 g (approximately 3 lbs. 5 oz.). Allergic colitis is themost common form of colitis during the first year of life.

IBD is generally diagnosed in children aged 5-16 years. It has a bimodaldistribution, with an early onset at age 15-25 years and a secondsmaller peak at age 50-80 years. The prevalence of IBD is increasedamong Jewish people of European Ashkenazi descent. A positive familyhistory is the most consistent risk factor for children with IBD. HSP iscommon in Caucasians. Food-allergic colitis is believed to be present inapproximately 0.5% of all infants.

Complications of IBD can include bleeding from the bowels, perforationin the colon, toxic mega colon, and ulceration of the colon. The mostserious acute complication of UC is toxic mega colon with the risk ofperforation. The risk of colon cancer increases after 8-10 years ofhaving UC. The complications of CD tend to increase with time andinclude bowel strictures, fistulas, abscess, and intestinal obstruction.After surgery, patients may develop short bowel syndrome andmal-absorption.

References to colitis can include:

-   Lee I A, H. Y. (2010). Berberine ameliorates TNBS-induced colitis by    inhibiting lipid peroxidation, enterobacterial growth and NF-κB    activation. European Journal of Pharmacology, 648(1-3):162-70;-   Zhang M, L. Y. (2011). Evidence for the complementary and    synergistic effects of the three-alkaloid combination regimen    containing berberine, hypaconitine and skimmianine on the ulcerative    colitis rats induced by trinitrobenzene-sulfonic acid. European    Journal of Pharmacology, 651(1-3): 187-96;-   Yan F, W. L. (2012). Berberine promotes recovery of colitis and    inhibits inflammatory responses in colonic macrophages and    epithelial cells in DSS-treated mice. American journal of    physiology. Gastrointestinal and liver physiology, 302(5):G504-14;-   Li G H, W. D. (2012). Berberine inhibits acute radiation intestinal    syndrome in human with abdomen radiotherapy. Medical Oncology,    27(3):919-25; and-   Kawashima K, N. A. (2004). Pharmacological properties of traditional    medicine (XXIX): effect of Hange-shashin-to and the combinations of    its herbal constituents on rat experimental colitis. Biological and    pharmaceutical bulletin, 1599-603.

Natural substances, such as artemisinin, as well as derivatives andmodifications thereof, have been used for many years as naturalmedications for treating infections and diseases caused by bacteria,viruses and parasites.

According to N. J. White in “Assessment of the pharmacodynamicproperties of antimalarial drugs in vivo” Antimicrobial. AgentsChemotherapy. 41 (7): 1413-1422 (July 1997), artemisinin, and itsderivatives are a group of herbal compounds that possess the most rapidaction of all current drugs against falciparum malaria. Treatmentscontaining an artemisinin derivative (artemisinin-combination therapies,ACTs) are now standard treatment worldwide for falciparum malaria. Thestarting compound artemisinin is isolated from the plant Artemisiaannua, an herb described in Chinese traditional medicine.

For many years after the discovery, access to the purified drug and theplant it was extracted from were restricted by the Chinese government.It was not until the later 1970s and early 80s that news of thediscovery reached scientists outside China. In 2006, after artemisininhad become the treatment of choice for malaria, the World HealthOrganization (WHO) called for an immediate halt to single-drugartemisinin preparations in favor of medications that combineartemisinin with another malaria drug, in order to reduce the risk ofparasites developing resistance, as reported in a WHO Media Center NewsRelease dated 19 Jan. 2006. Thus the use of artemisinin by itself as amonotherapy is explicitly discouraged by the World Health Organizationbecause there are signs that malarial parasites are developingresistance to artemisinin alone.

Following is a list of patents that focus on the chemistry ofartemisinin and its derivatives which include artesunate,dihydroArtemisinin and derivatives thereof used in antimalarials, mixedsteroidal compounds, trioxane derivatives, and the like. U.S. Pat. No.7,098,242 to ElSohly et al.; U.S. Pat. No. 7,071,226 to Singh et al.;U.S. Pat. No. 6,984,640 to Haynes et al.; U.S. Pat. No. 6,906,205 toVennerstrom et al.; U.S. Pat. No. 6,906,098 to Solaja et al.; U.S. Pat.No. 6,750,356 to Bhakuni et al.; U.S. Pat. No. 6,737,438 to Singh etal.; U.S. Pat. No. 6,685,972 to Kumar et al.; U.S. Pat. No. 6,683,193 toBhakuni et al.; U.S. Pat. No. 6,649,647 to Haynes et al.; U.S. RE38,117to Zheng et al.; U.S. Pat. No. 6,461,603 to Bentley et al.; U.S. Pat.No. 6,346,631 to Jain et al.; U.S. Pat. No. 6,306,896 to Scheiwe; U.S.Pat. No. 6,160,004 to Posner et al.; U.S. Pat. No. 6,136,847 to Posneret al.; U.S. Pat. No. 6,127,405 to Kumar et al.; U.S. Pat. No. 5,856,351to Zheng et al.; U.S. Pat. No. 5,225,562 to McChesney et al.; and U.S.Pat. No. 5,225,427 to Venugopalan et al.

U.S. patents covering various uses of berberine and derivatives thereofinclude U.S. Pat. Nos. 5,153,178; 4,980,344; 4,749,708; and 4,761,417 toMaroko.

Various patents provide the state of the art for synthetic drugscombined with natural herbal compounds, such as, artemisinin andberberine; the combination includes chemical and natural ingredients. Arepresentative sample of patents and patent publications is providedbelow.

U.S. Pat. No. 8,026,209 to Gaillard et al. identifies antimalarials,such as artemisinin and berberine in the production of pharmaceuticalcompositions for targeting agents into and across the blood-barrier andother endothelial cell microvascular barriers.

U.S. Pat. No. 7,947,846 to Frincke discloses use of synthesizedcompounds to treat thrombocytopenia, neutropenia or delayed effects ofradiation therapy and mentions that optional administration ofadditional therapeutic treatments could include analogs for viralinfections or antimalarial agents such as artemisinin and berberine.

U.S. Pat. No. 7,935,839 to Frincke discloses sepsis treatment methodsfor cystic fibrosis, neutropenia that could include optionallyadministered additional therapeutic treatment from antimalarials, suchas artemisinin and berberine.

U.S. Pat. No. 7,915,223 to Mor et al. discloses a novel class ofantimicrobial polymeric agents and pharmaceutical compositionscontaining the same for treating medical conditions associated withpathological microorganisms and more. Mor et al. mentions artemisinin incombination with other drugs is preferred treatment for resistantstrains of malaria.

U.S. Pat. No. 7,547,687 to Reading et al. discloses compounds used fortreatment of cystic fibrosis, neutropenia that could include optionallyadministered additional therapeutic treatment from antimalarials, suchas artemisinin and berberine.

U.S. Pat. No. 7,482,334 to Frincke et al. mentions therapeutic treatmentmethods using synthetic compounds and natural substances to ameliorateor treat cystic fibrosis, neutropenia and other conditions.

U.S. Pat. No. 5,413,928 to Weathers et al. references plants grown invitro can provide a major source of specialty chemicals, which are plantsecondary metabolites, such as artemisinin, a terpenoid found in theherb, Artemisia annua, to provide therapeutic treatment for malaria.Weathers et al. also reference that berberine, an alkaloid compound, canbe extracted from the roots, rhizomes, stems and bark of a variety ofBerberis plants, such as Oregon grape, Barberry, Tree Turmeric,Goldenseal, and others.

ActRx at website http.//actrxlimited.com/ (n.d.). retrieved October 2012from ActRx: www.actrxlimited.com offers for sale a malaria-Dengueformular stating that all ingredients are rated GRAS (GenerallyRecognized As Safe); the ActRx adult formula has packet A, serving sizetwo tables; artesnunate 50 mg and packet B Berberine alkaloid, servicesize two tablets 800 mg; and ActRx 80 mg injectable for malaria (noformula given). The product is packaged and offered in a manner thatcould lead to a consumer taking packet A and not packet B or vice versaand otherwise resulting in ineffective remediation of the disease orinfection.

Thus, the prior art suggests that many chemical and natural compoundscan be combined to provide therapeutic treatment for diseases, such asmalaria. What is absent in the prior art is a formulation that combines,in one unit, such as a pill or tablet, two all-natural, herbalsubstances, namely, artemisinin and berberine, to deliver activetherapeutic substances to relieve suffering from devastating infectiousdiseases, including, but not limited to malaria, yellow fever, denguefever, dysentery, Lyme disease, babesiosis, progressive multifocalleukoencephalopathy, Helicobacter Pylori, and colitis.

There is also an obvious need for an ACT with a more effective andpassively accurate delivery system, devoid of quinine, with all naturalactive ingredients, and in a form accessible and agreeable to children.The present invention fulfills this need as a treatment and as apreventive agent.

SUMMARY OF THE INVENTION

The first objective of the present invention is to provide a compositionof all-natural herbal ingredients for adults combining artemisinin andberberine formulated to deliver in one single unit or pill atherapeutically effective treatment for malaria, dengue fever,dysentery, yellow fever, Lyme disease, babesiosis, progressivemultifocal leukoencephalopathy, Helicobacter Pylori, and colitis.

The second objective of the present invention is to provide acomposition of all-natural herbal ingredients for children combiningartemisinin and berberine formulated to deliver in one single unit orpill a therapeutically effective treatment for malaria, dengue fever,dysentery, yellow fever, Lyme disease, babesiosis, progressivemultifocal leukoencephalopathy, Helicobacter Pylori, and colitis.

The third objective of the present invention is to provide a compositionof all-natural herbal ingredients for adults combining artemisinin andberberine formulated to deliver a single pill for the prevention ofmalaria, dengue fever, dysentery, yellow fever, Lyme disease,babesiosis, progressive multifocal leukoencephalopathy, HelicobacterPylori, and colitis.

The fourth objective of the present invention is to provide acomposition of all-natural herbal ingredients for children combiningartemisinin and berberine formulated to deliver a chewable tablet ordosing system for prevention of malaria, dengue fever, dysentery, yellowfever, Lyme disease, babesiosis, progressive multifocalleukoencephalopathy, Helicobacter Pylori, and colitis.

The fifth objective of the present invention is to provide a compositionof all-natural herbal ingredients combining artemisinin and berberinefor treatment and prevention of chloroquine-resistant and anti-malarialdrug-resistant strains of malaria in humans or animals.

The sixth objective of the present invention is to provide a compositionof all-natural herbal ingredients combining artemisinin and berberinethat is devoid of quinine or quinine derivatives for treatment andprevention malaria, dengue fever, dysentery, yellow fever, Lyme disease,babesiosis, progressive multifocal leukoencephalopathy, HelicobacterPylori, and colitis, in humans or animals.

The seventh objective of the present invention is to provide acomposition of all-natural herbal ingredients combining artemisinin andberberine in a single pill, tablet, capsule, or delivery system thatfunctions as a passively accurate dosing and delivery system fortreatment and prevention of malaria, dengue fever, dysentery, yellowfever, Lyme disease, babesiosis, progressive multifocalleukoencephalopathy, Helicobacter Pylori, and colitis, in humans oranimals.

An eighth objective of the invention is to provide natural botanicalingredients and compositions and methods of making and combiningartemisinin, berberine, capsaicin, and papaya extract to produce anAlternative ACT that delivers active therapeutic treatment andprevention of diseases and infections caused by bacteria, viruses andparasites, and more specifically for the treatment of chikungunya.

An artemisinin and berberine treatment composition for treating apatient in a single pill, tablet or capsule can include artemisinin,berberine, and at least one binding or delivery component, wherein thecomposition is useful for treating an adult in a single pill, tablet orcapsule, for at least one illness selected from the group comprisingmalaria, dengue fever, dysentery, yellow fever, Lyme disease andbabesiosis, progressive multifocal leukoencephalopathy, HelicobacterPylori, and colitis.

The treatment composition can be used for an adult patient and includesa broad range 50 mg-120 mg artemisinin, and 350 mg-1000 mg berberine. Apreferred range can include 90 mg-110 mg artemisinin and 600 mg-900 mgberberine. An example can include approximately 100 mg artemisinin andapproximately 800 mg berberine.

For the adult application, the at least one binding or deliverycomponent can be selected from the group comprising: microcrystallinecellulose, stearic acid, silicon dioxide, calcium carbonate, magnesiumstearate, and croscarmellose sodium.

The treatment composition can be used for an child patient and include12.5 mg-30 mg artemisinin and 87.5 mg-250 mg berberine. A preferredrange can include 22.5 mg-27.5 mg artemisinin and 150 mg-225 mgberberine. An example can include approximately 25 mg artemisinin andapproximately 200 mg berberine.

For the child patient, the at least one binding or delivery componentcan be selected from the group comprising: peppermint, xylitol,maltodextrin, sucralose, silicon dioxide, calcium carbonate, andprecipitated silica.

Another artemisinin and berberine composition for treating a patient ina single pill, tablet or capsule can include the combination ofartemisinin. berberine, and a blended mixture of up to approximately 400mg of black walnut (Juglans nigra) dry outer hull and up toapproximately 500 mg of wormwood (Artemisia absinthium) dry flower andleaf; up to approximately 150 mg of Clove (Syzygium aronalicum) dryflower; and up to approximately 700 mg of Chinese wormwood (Artemisiaannua), wherein the composition is useful for prevention of at least oneof malaria, dengue fever, dysentery, yellow fever, Lyme disease,babesiosis, progressive multifocal leukoencephalopathy, HelicobacterPylori, and colitis.

A method for making an artemisinin and berberine composition for apatient in a single pill, tablet, capsule, gelcap, oral suspension,sublingual or transdermal patch, or any other therapeutic preparationcan include the steps of providing a mixer, mixing artemisinin andberberine in the mixer to form mixture (I), mixing at least one bindingor delivery component with mixture (I) to form mixture (II), filteringmixture (II) through at least one filter to form mixture (III),granulating mixture (III) in a granulator to produce granulated chips,pressing the granulated chips into tablets (mixture IV), removing dustfrom the tablets by cleaning and vacuuming the tablets, applying anenteric shell coating to the cleaned and vacuumed tablets heating andtumbling the coated tablets, and packaging the heated and tumbled coatedtablets in a package.

The method for making an artemisinin and berberine composition caninclude the steps of selecting 50 mg-120 mg artemisinin and selecting350 mg-1000 mg berberine.

The method for making an artemisinin and berberine composition caninclude the steps of selecting the at least one binding or delivercomponent is selected from the group comprising: microcrystallinecellulose, stearic acid, silicon dioxide, calcium carbonate, magnesiumstearate, and croscarmellose sodium.

The method for making an artemisinin and berberine composition caninclude the steps of selecting 12.5 mg-30 mg artemisinin, and selecting87.5 mg-250 mg berberine.

The method for making an artemisinin and berberine composition caninclude the steps of selecting the at least one binding or delivercomponent is selected from the group comprising: peppermint, xylitol,maltodextrin, sucralose, silicon dioxide, calcium carbonate, andprecipitated silica.

A therapeutic treatment composition, can consist only of a mixture ofartemisinin and berberine in a single capsule, wherein the compositionis adaptable for treatment of mammals, or birds with an infection causedby at least one of a parasite, a bacteria, a virus, and a combinationthereof. The infection can be selected from the group comprisingmalaria, dengue fever, dysentery, yellow fever, Lyme disease andbabesiosis, progressive multifocal leukoencephalopathy, HelicobacterPylori, and colitis.

The mixture can include 50 mg-120 mg artemisinin and 350 mg-1000 mgberberine. The mixture can also include 12.5 mg-30 mg artemisinin and87.5 mg-250 mg berberine.

Natural botanical ingredients and compositions and methods of making andcombining artemisinin, berberine, capsaicin, and papaya extract toproduce an Alternative ACT that delivers active therapeutic treatmentand prevention of diseases and infections caused by bacteria, virusesand parasites, and more specifically for the treatment of chikungunya.

Further objects and advantages of this invention will be apparent fromthe following detailed description of a presently preferred embodiment,when read in conjunction with the appended claims.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a graph of a Lyme focus group survey results for ratingquality of life.

FIG. 2 is a graph of Lyme focus group survey results requestingparticipants to rate how easy it is to bend, kneel or stoop.

FIG. 3 is a Lyme focus group survey results for rating everydayactivities.

FIG. 4 is a Lyme focus group survey results for rating vigorousactivities.

FIG. 5 is a Lyme focus group survey results for rating bath, shower anddress capability.

FIG. 6 is a Lyme focus group survey results for rating appetite and foodconsumption.

FIG. 7 is a Lyme focus group survey results for rating intake of fluids.

FIG. 8 is a Lyme focus group survey results for rating ability to moveand turn neck.

FIG. 9 is a Lyme focus group survey results for rating ability to situpright and do activities.

FIG. 10 is a Lyme focus group survey results for rating sensitivity tolight.

FIG. 11 is a Lyme focus group survey results for rating sensitivity tosound.

FIG. 12 is a Lyme focus group survey results for rating overall level ofjoint pain.

FIG. 13 is a Lyme focus group survey results for rating overall mood.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before explaining the disclosed embodiment of the present invention indetail, it is to be understood that the invention is not limited in itsapplication to the details of the particular arrangement shown since theinvention is capable of other embodiments. Also, the terminology usedherein is for the purpose of description and not of limitation.

The delivery system described in this patent includes, but is notlimited to, the following methods of packaging: blister packs, zip lockpacks, standup pouches, foil pouches, boxes, jars, bottles, single dosepackets, one a day packs, two day packs, three day packs, four daypacks, five day packs, six day packs, seven day packs, 8, 9, 10, 11, 12or 13 or more day packs, fourteen day packs, 15, 16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, 27, 28, 29 and thirty day packs or more, sixty daypacks, ninety day packs, spray bottles, fast melt pill format, bursts,gel format adhesive bandages, skin patches, gelcaps, softgels, gelatincapsules, vegetarian capsules, hard shell gelatin capsules, injections,intravenous solutions, topical creams, topical ointments, suppositories,or sublingual methods of administration known to those versed in theart.

It would be useful to discuss the meanings of some words used herein andtheir applications before discussing the compositions of matter andmethod of using as a carrier in a topical skin application.

The acronym ACT is used herein to mean “Artemisinin Combination Therapy”which includes artemisinin and its derivatives in combination with othertherapeutic substances.

The compound “crosmellose sodium” is an internally cross-linked sodiumcarboxy-methylcellulose for use as a disintegrant in pharmaceuticalformulations. The cross-linking reduces water solubility while stillallowing the material to swell (like a sponge) and absorb many times itsweight in water. As a result, it provides superior drug dissolution anddisintegration characteristics, thus improving formulas' subsequentbioavailability by bringing the active ingredients into better contactwith bodily fluids.

Croscarmellose sodium also resolves formulators' concerns over long-termfunctional stability, reduced effectiveness at high tablet hardnesslevels, and similar problems associated with other products developed toenhance drug dissolution. Croscarmellose sodium is a very commonly usedpharmaceutical additive approved by the U.S. Food and DrugAdministration. Its' purpose in most tablets—including dietarysupplements—is to assist the tablet in disintegrating in the intestinaltract at the required location.

The term “dysentery” is used herein to include diarrhea, cholera andtraveler's diarrhea. Acute diarrhea is usually related to a bacterial,viral, or parasitic infection. Chronic diarrhea is usually related tofunctional disorders such as irritable bowel syndrome or inflammatorybowel disease. Cholera is an acute infection in humans involving theentire small bowel, characterized by a debilitating diarrhea. Traveler'sdiarrhea is the most common illness affecting travelers. The mostimportant determinant of risk is the traveler's destination with theprimary source of infection being the ingestion of fecally contaminatedfood or water. Common culprits causing the disorder includeCampylobacter, Salmonella, Shigella and Escherichia coli (E. coli).

The term “excipient” is used herein to mean an inert substance added toa pharmaceutical composition to further facilitate administration of thecompound. Excipients can include flavors, sugars, starches, cellulosederivatives, gelatin, calcium carbonate, magnesium stearate, silicondioxide, masking agents and the like.

The term “preventative” and “prevent” is used herein to mean avoidingand preventing the appearance of clinical symptoms of a condition.

The term “therapeutically effective amount” is used herein to describean amount of the composition being administered which will relieve tosome extent or prevent one or more of the symptoms of the conditionbeing treated.

The term “treating” and “treatment” is used herein to mean abrogating,substantially inhibiting, slowing or reversing the progression of acondition, substantially ameliorating clinical symptoms of a condition.

The present invention comprises all natural active ingredientsformulated with various selected excipients to provide the treatmentsand therapies disclosed herein. This is an advantage over the prior artwherein chemicals and synthetic drugs are used for treatment andprevention. The use of chemicals can cause harmful side effects.

Before discussing the compositions of the present invention and themethod for making, a brief discussion is provided of each of theall-natural active ingredients, artemisinin and berberine.

Artemisinin is produced from a plant-based source, the Artemisia annua.China and Vietnam provide 70% and East Africa 20% of the raw material.Seedlings are grown in nurseries and then transplanted into fields. Ittakes about 8 months to reach full size. The plants are harvested, theleaves are dried and sent to facilities where the artemisinin isextracted using solvent, typically hexane. Artemisinin and itsderivative forms are commercially available from India or China. Onesupplier of artemisinin is Tai'an Zhonghui Plant Biochemical Co., Ltd.Taifeng Road, No. 88, Zhaizhen Industry District, Xintai, Shandong,China. Artemisinin and its derivatives have half-lives in the order of afew hours and thus require at least daily dosing for several days.

Berberine is a strongly yellow colored quaternary ammonium salt, knownas an alkaloid. It is found in the roots, rhizomes, stems and bark of avariety of plants, including, but not limited to Barberry, TreeTurmeric, Goldenseal, Prickly Poppy, Californian Poppy and the like. Inaddition to use as a natural dye, berberine is considered an antibioticand has been included in formulations as a traditional medicine ordietary supplement to treat fungal infections, Candida albicans, yeast,parasites, bacterial/viral infections, and eye infections with widepotential therapeutic properties.

Berberine is commercially available. One of many suppliers is HopelandChem-Tech Co., Ltd. Rm.2-0103, Gaoke Plaza D, No. 3, 4^(th) Gaoxin Road,Xi'an City, Shaanxi Province, China. Berberine is one of the bitterestsubstances known. It is also difficult to work within the formation ofdry, physically stable pills due to its water content, which isapproximately 14 weight %.

Not to be bound by any theory, it is believed that artemisinin destroysthe bacteria, virus or parasite in the blood and berberine destroys theweakened, but still viable bacteria, virus or parasite in theintestines. Artemisinin and berberine combined have no known toxicity tohumans at the dosage levels required for effective treatment andprevention of infections caused by bacteria, viruses and parasites inhumans.

Table IA below provides a list of ingredients that are used to provide abasic formulation of artemisinin and berberine (AB) for treatment of anadult person suffering from malaria, dengue fever, dysentery, yellowfever, Lyme disease or babesiosis. Table 1A is intended to cover anaverage adult weighing approximately 180 pounds (approximately 81.65kg).

TABLE IA Treatment Composition mg per pill for Adult Broad PreferredPreferred Component - Range (mg Range (mg Amt Substitution Adult Dosingper Pill) per Pill) (mg per Pill) Category ACTIVE INGREDIENTSartemisinin  50-120  90-110 approx mg mg 100 mg berberine 350-1000600-900 approx mg mg 800 mg INERT For binding or delivery of otheringredients. INGREDIENTS microcrystalline  0-650 400-650 approx 540 Binders and cellulose compaction stearic acid  0-200 200-400 approx 300 Lubricant excipient silicon  0-50 30-50 approx 40  Water dioxidereducing agent and promote absorption of water and prevent caking andclumping calcium   0-1100  800-1100 approx 1000 Inert filler carbonatemagnesium  0-90 60-90 approx 75  For stearate lubricating properties andto prevent powdered component from sticking to pill press equipmentduring compression from powder into solid tablets croscarmellose  0-5035-50 approx 40  To reduce sodium water solubility and allow material toexpand, absorbing many times its weight in water and removing much ofthe water from berberine.

Approximately is defined as +1-5% in order to cover manufacturingvariances and dosing tolerances.

The inert ingredients are not therapeutic and are designed for theintegrity, palatability and stability of the tablets. There are manysubstitutes for the various classes of inert ingredients that caninclude disintegrants, lubricants, binders, and excipients.

Disintegrants can include, but are not limited to guar gums, ionexchange resins, gums, micro-crystalline cellulose, aginates, cellulose,starches, sodium starch glycolate, cross povidone, gum karaya, chitinand chitosan, smecta, gullan gums, isapghula husk, polacrillanpotassium, and agar.

Lubricants can include but are not limited to stearic acid, magnesiumstearate, silica, hydrogenated vegetable oil, mineral oil, polyethyleneglycol, glyceryl palmitostearate, glyceryl bahenate, sodium benzoate,sodium stearyl fumarate, talc, and silicon dioxide.

Binders can include but are not limited to acacia, alginic acid,aluminum hydroxide, calcium hydroxide, calcium oxide, carboxymethylcellulose, cellulose, ethyl cellulose, gelatin, guar gum, maltodextrin,methyl cellulose, polyethylene glycol, povidone.

Excipients can include but are not limited to flavorings, cellulosederivatives, calcium carbonate, magnesium stearate, silicon dioxide,masking agents, saccharides and their derivatives, gelatin, Syntheticpolymers, coatings and enterics, fillers and stearates. dehydratingagents or desiccating agents.

Desiccating agents can include but are not limited to sodium carboxymethyl cellulose, silica gel, microcrystalline cellulose,carboxymethylcellulose calcium, cellulose, colloidal silicone dioxide,and crosscarmellose sodium.

Table IB covers a dose per body weight (in mg per kg) for customizingdosages for adults less than or greater than 180 pounds (81.65 kgs).

TABLE IB DOSE PER BODY WEIGHT FOR ADULTS (mg per kg) Component - BroadRange Preferred Range Preferred Amt Substitution Adult Dosing (mg perkg) (mg per kg) ((mg per kg) Category ACTIVE INGREDIENTS artemisinin22.69-54.43 40.92-49.90 approx 45.36 berberine 158.76-453.60272.15-408.03 approx 362.87 INERT For binding or delivery of otheringredients. INGREDIENTS microcrystalline    0-294.83 181.99-294.83approx 244.94 Binders and cellulose compaction stearic acid    0-181.44 90.72-181.44 approximately Lubricant excipient 136.08 silicon dioxide   0-22.68 13.61-22.68 approx 18.14 Water reducing agent and to promoteabsorption of water and prevent caking and clumping calcium    0-498.95362.89-498.95 approx 453.59 Inert filler carbonate magnesium    0-40.8227.22-40.82 approx 34.02 For lubricating stearate properties and toprevent powdered component from sticking to the pill press equipmentduring the compression from powder into solid tablets croscarmellose   0-22.68 15.88-22.68 approx 18.14 To reduce water sodium solubilityand allow the material to expand, absorbing many times its weight inwater and removing much of the water from Berberine.

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin andberberine in the amounts referenced in the above tables.

For adults, defined as persons over the body weight of 110 pounds, onetablet can be one serving size and recommended directions for taking theanti-malarial composition are as follows:

Day 1—Take one tablet in the morning

-   -   Take one tablet in the evening        Day 2—Take one tablet in the morning    -   Take one tablet in the evening        Day 3—Take one tablet in the morning        Day 4—Take one tablet in the morning

Table II illustrates an Adult Treatment Dosing rate.

TABLE II Adult Treatment Dosing Dosing Day 1 Day 2 Day 3 Day 4 AM OneTablet One Tablet One Tablet One Tablet PM One Tablet One Tablet

The four-day dosage regimen outlined above in Table II as ananti-malarial treatment requires the consumption of a total of 6 tabletsover a consecutive four-day period and is also the dosage regimen usedin the treatment of dengue fever, dysentery and yellow fever. The dosageregimen for Lyme disease requires the consumption of eighteen tabletsover twenty-four consecutive days as shown in Table III.

TABLE III Adult Dosing, Lyme Disease Phase 1 Day 1 Day 2 Day 3 Day 4 Day5 Day 6 Day 7 Day 8 AM 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1Tablet 1 Tablet 1 Tablet PM 1 Tablet 1 Tablet Phase 2 Day 9 Day 10 Day11 Day 12 Day 13 Day 14 Day 15 Day 16 No No No No No No No No Dose DoseDose Dose Dose Dose Dose Dose Phase 3 Day 17 Day 18 Day 19 Day 20 Day 21Day 22 Day 23 Day 24 AM 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1 Tablet 1Tablet 1 Tablet 1 Tablet

Table IVA provides the formulation of a chewable tablet for children inmg per pill.

Table IVA covers for children having a weight of 27.2 kg (60 pounds).

TABLE IVA Treatment Composition for Children in mg per pill Children'sComponent Dosing Broad Preferred Preferred Substitution [mg/Pill] RangeRange Amount Category ACTIVE IN- GREDIENTS artemisinin 12.5-30  22.5-27.5 approx 25 berberine 87.5-250  150-225 approx 200 INACTIVE Forbinding or delivery of other ingredients. INGREDI- ENTS peppermint  0-7035-70 approx 50 Flavoring xylitol    0-1,200   800-1,200 approx 1,000Sweetener 83%  0-120  80-120 approx 100 Masking maltodextrin Agent and17% natural flavors sucralose  0-12  8-12 approx 10 Sweetener INERT Forbinding INGREDI- or delivery ENTS of other ingredients silicon  0-220160-220 approx 200 Water dioxide reducing agent that promotes absorptionof water and prevents caking or clumping calcium    0-1,200   800-1,200approx 1,000 Inert filler carbonate precipitated  0-29 23-29 approx26.66 Anticaking, silica free flow agent

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin andberberine in the amounts referenced in the above tables.

The inert ingredients are not therapeutic and are designed for theintegrity, palatability and stability of the tablets. There are manysubstitutes for the various classes of inert ingredients that caninclude disintegrants, lubricants, binders, excipients

Disintegrants can include guar gums, ion exchange resins, gums,micro-crystalline cellulose, aginates, cellulose, starches, sodiumstarch glycolate, cross povidone, gum karaya, chitin and chitosan,smecta, gullan gums, isapghula husk, polacrillan potassium, and agar.

Lubricants can include but are not limited to stearic acid, magnesiumstearate, silica, hydrogenated vegetable oil, mineral oil, polyethyleneglycol, glyceryl palmitostearate, glyceryl bahenate, sodium benzoate,sodium stearyl fumarate, talc, and silicon dioxide.

Binders can include but are not limited to acacia, alginic acid,aluminum hydroxide, calcium hydroxide, calcium oxide, carboxymethylcellulose, cellulose, ethyl cellulose, gelatin, guar gum, maltodextrin,methyl cellulose, polyethylene glycol, and povidone.

Excipients can include but are not limited to flavorings, cellulosederivatives, calcium carbonate, magnesium stearate, silicon dioxide,masking agents, saccharides and their derivatives, gelatin, syntheticpolymers, coatings and enterics, fillers and stearates.

Dehydrating Agents or Desiccating Agents can include but are not limitedto sodium carboxy methyl cellulose, silica gel, microcrystallinecellulose, carboxymethylcellulose calcium, cellulose, colloidal siliconedioxide and crosscarmellose sodium.

Table IVB covers a dose per body weight (in mg per kg) for customizingdosages for children having weights of less than 100 pounds (45.36 kgs).

TABLE IVB DOSE PER BODY WEIGHT FOR CHILDREN (mg per kg) Component BroadPreferred Preferred Children's Range Range Amount Substitution Dosingmg/kg mg/kg mg/kg Category ACTIVE INGREDIENTS artemisinin  5.67-13.6110.21-12.47 approx 11.39 berberine  39.69-113.40  68.04-102.06 approx90.72 INACTIVE For binding or delivery of other ingredients. INGREDIENTSpeppermint    0-31.75 15.88-31.75 approx 22.68 Flavoring xylitol   0-544.31 362.87-544.31 approx 453.60 Sweetener 83% maltodextrin   0-54.43 36.29-54.43 approx 45.36 Masking Agent & 17% natural flavorssucralose   0-5.44 3.63-5.44 approx 4.54 Sweetener INERT For binding orINGREDIENTS delivery of other ingredients silicon dioxide    0-99.7972.57-99.79 approx 90.72 Water reducing agent that promotes absorptionof water and prevents caking or clumping calcium carbonate    0-544.31362.87-544.31 approx 453.60 Inert filler precipitated silical    0-13.1510.43-13.15 approx 12.09 Anticaking, free flow agent

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin andberberine in the amounts referenced in the above tables.

For children, defined as persons between the ages of 2 and 12 with abody weight below 110 pounds, children's dosage size is two tablets;thereby providing approximately 50 mg artemisinin per dosage. Tabletscan be chewed or dissolved in the mouth. Directions for taking theanti-malarial formula are as follows:

Day 1—Take two tablets in the morning

-   -   Take two tablets in the evening        Day 2—Take two tablets in the morning    -   Take two tablets in the evening        Day 3—Take two tablets in the morning        Day 4—Take two tablets in the morning

The four-day dosage regimen outlined above as an anti-malarial treatmentrequires the consumption of a total of 12 tablets over a consecutivefour-day period and is also the dosage regimen used in the treatment ofdengue fever, dysentery and yellow fever.

The dosage regimen for Lyme disease requires the consumption ofthirty-six tablets over twenty-four consecutive days is shown in TableV.

TABLE V Children's Dosing, Lyme Phase 1 Day 1 Day 2 Days 3-8 AM 2 2 2Chewables Chewables Chewables PM 2 2 Chewables Chewables Phase 2 Day 9Day 10 Days 11-16 No Dose No Dose No Dose Phase 3 Day 17 Day 18 Days19-24 AM 2 2 2 Chewables Chewables Chewables

Table VIA shows a table for the preventative composition for adults inmg per pill.

TABLE VIA Preventative Composition for Adults in mg per pill ComponentPreventative Adult Dosing Broad Preferred Preferred Substitution[mg/Pill] Range Range Amount Category ACTIVE INGREDIENTS artemisinin 50-120 mg  90-110 mg approx 100 mg berberine 350-1000 mg 600-900 mgapprox 800 mg BLENDED   0-500 mg 300-500 mg approx 350 mg Excipient withMIXTURE* Active Ingredients INERT For binding or delivery of otheringredients. INGREDIENTS microcrystalline  0-650 400-650 approx 540Binders and cellulose compaction stearic acid  0-200 200-400 approx 300Lubricant excipient silicon dioxide  0-50 30-50 approx 40 Water reducingagent and to promote absorption of water and prevent caking and clumpingcalcium carbonate   0-1100  800-1100 approx 1000 Inert filler magnesium 0-90 60-90 approx 75 For lubricating stearate properties and to preventpowdered component from sticking to the pill press equipment during thecompression from powder into solid tablets croscarmellose  0-50 35-50approx 40 To reduce sodium water solubility and allow the material toexpand, absorbing many times its weight in water and removing much ofthe water from Berberine.

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin andberberine in the amounts referenced in the above tables.

The inert ingredients are not therapeutic and are designed for theintegrity, palatability and stability of the tablets. There are manysubstitutes for the various classes of inert ingredients that caninclude disintegrants, lubricants, binders and excipients.

Disintegrants can include but are not limited to guar gums, ion exchangeresins, gums, micro-crystalline cellulose, aginates, cellulose,starches, sodium starch glycolate, cross povidone, gum karaya, chitinand chitosan, smecta, gullan gums, isapghula husk, polacrillanpotassium, and agar.

Lubricants can include but are not limited to stearic acid, magnesiumstearate, silica, hydrogenated vegetable oil, mineral oil, polyethyleneglycol, glyceryl palmitostearate, glyceryl bahenate, sodium benzoate,sodium stearyl fumarate, talc, and silicon dioxide.

Binders can include but are not limited to acacia, alginic acid,aluminum hydroxide, calcium hydroxide, calcium oxide, carboxymethylcellulose, cellulose, ethyl cellulose, gelatin, guar gum, maltodextrin,methyl cellulose, polyethylene glycol, and povidone.

Excipients can include but are not limited to flavorings, cellulosederivatives, calcium carbonate, magnesium stearate, silicon dioxide,masking agents, saccharides and their derivatives, gelatin, syntheticpolymers, coatings and enterics, fillers and stearates.

Dehydrating Agents or Desiccating Agents can include but are not limitedto sodium carboxy methyl cellulose, silica gel, microcrystallinecellulose, carboxymethylcellulose calcium, cellulose, colloidal siliconedioxide, and crosscarmellose sodium.

*The blended mixture referenced in Table VI can include a blendedmixture approximately 400 mg of concentrate of black walnut (Juglansnigra) dry outer hull; approximately 500 mg of concentrate oforganically grown wormwood (Artemisia absinthium) dry flower and leaf;approximately 150 mg of concentrate of Clove (Syzygium aronalicum) dryflower; and approximately 700 mg of fresh leaf organically grown Chinesewormwood (Artemisia annua).

The concentrate of black walnut is an astringent that supports theintestinal system. Organically grown wormwood is used to improveappetite, aid in digestive functions, and assist in the absorption ofnutrients. The concentrate of Clove is a carminative, to increasehydrochloric acid in the stomach and to improve peristalsis. Chinesewormwood is used to reduce and stop fever.

For adults, defined as persons with a body weight of at least 110pounds, one capsule per day with a meal is taken for 7 to 14 daysdepending on the number of days desired to stay parasite free. Onecapsule per day for 7 to 14 days is effective for preventing infectionfor 30 to 60 days, respectively. A dosage of one capsule a day for 14-28days is effective for preventing Lyme disease for 30 to 60 days,respectively.

Table VIB covers a dose per body weight (in mg per kg) for customizingdosages for adults less than or greater than 180 pounds (81.65 kgs).

TABLE VIB DOSE PER BODY WEIGHT FOR ADULTS (mg per kg) ComponentPreventative Broad Preferred Preferred Substitution Adult Dosing RangeRange Amount Category [mg/kg] mg/kg mg/kg mg/kg mg/kg ACTIVE INGREDIENTSartemisinin 22.68-54.43 40.82-49.89 approx 45.36 berberine 158.76-453.60272.15-408.23 approx 362.87 BLENDED    0-226.80 136.08-226.80 approx158.76 Excipient with MIXTURE* Active Ingredients INERT For binding ordelivery of other ingredients. INGREDIENTS microcrystalline    0-294.83181.94-294.83 approx 244.94 Binders and cellulose compaction stearicacid    0-181.44  90.72-181.44 approx 136.08 Lubricant excipient silicondioxide    0-22.68 13.61-22.68 approx 18.14 Water reducing agent and topromote absorption of water and prevent caking and clumping calciumcarbonate    0-498.95 362.89-498.95 approx 453.59 Inert filler magnesium   0-40.82 27.22-40.82 approx 34.02 For lubricating stearate properties& to prevent powdered component from sticking to pill press equipmentduring compression from powder into solid tablets croscarmellose   0-22.68 15.88-22.68 approx 18.14 To reduce sodium water solubilityand allow the material to expand, absorbing many times its weight inwater and removing much of the water from Berberine.

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin andberberine in the amounts referenced in the above tables.

Table VIIA shows the formulation of a chewable tablet for children.

TABLE VIIA Preventative Composition for Children in mg per pillComponent Preventative Children Dosing Broad Preferred PreferredSubstitution [mg/Pill] Range Range Amount Category ACTIVE INGREDIENTSartemisinin 12.5-30 mg 22.5-27.5 mg   approx 25 mg berberine 87.5-250mg  150-225 mg approx 200 mg BLEND  0-200 150-200 approx 175 mgExcipient with MIXTURE* Active Ingredients INACTIVE INGREDIENTSpeppermint  0-70 35-70 approx 50 Flavoring xylitol   0-1200  800-1200approx 1000 Sweetener 83%  0-120  80-120 approx 100 Masking maltodextrinAgent and 17% natural flavors Sucralose  0-12  8-12 approx 10 SweetenerINERT For binding or delivery of other ingredients INGREDIENTS silicondioxide  0-220 160-220 approx 200 Water reducing agent that promotesabsorption of water and prevents caking or clumping calcium carbonate  0-1200  800-1200 approx 1000 Inert filler precipitated silica  0-2923-29 approx 26.66 Anticaking, free flow agent

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin andberberine in the amounts referenced in the above tables.

*The blend mixture can consist of a blended mixture approximately 400 mgof concentrate of black walnut (Juglans nigra) dry outer hull;approximately 500 mg of concentrate of organically grown wormwood(Artemisia absinthium) dry flower and leaf; approximately 150 mg ofconcentrate of Clove (Syzygium aronalicum) dry flower; and approximately700 mg of fresh leaf organically grown Chinese wormwood (Artemisiaannua).

The concentrate of black walnut is an astringent that supports theintestinal system. Organically grown wormwood is used to improveappetite, aid in digestive functions, and assist in the absorption ofnutrients. The concentrate of Clove is a carminative, to increasehydrochloric acid in the stomach and to improve peristalsis. Chinesewormwood is used to reduce and stop fever.

The inert ingredients are not therapeutic and are designed for theintegrity, palatability and stability of the tablets. There are manysubstitutes for the various classes of inert ingredients that caninclude disintegrants, lubricants, binders, and excipients. Thefollowing classes can include but are not limited to:

Disintegrants can include but are not limited to guar gums, ion exchangeresins, gums, micro-crystalline cellulose, aginates, cellulose,starches, sodium starch glycolate, cross povidone, gum karaya, chitinand chitosan, smecta, gullan gums, isapghula husk, polacrillanpotassium, and agar.

Lubricants can include but are not limited to stearic acid, magnesiumstearate, silica, hydrogenated vegetable oil, mineral oil, polyethyleneglycol, glyceryl palmitostearate, glyceryl bahenate, sodium benzoate,sodium stearyl fumarate, talc, and silicon dioxide.

Binders can include but are not limited to acacia, alginic acid,aluminum hydroxide, calcium hydroxide, calcium oxide, carboxymethylcellulose, cellulose, ethyl cellulose, gelatin, guar gum, maltodextrin,methyl cellulose, polyethylene glycol, and povidone.

Excipients can include but are not limited to flavorings, cellulosederivatives, calcium carbonate, magnesium stearate, silicon dioxide,masking agents, saccharides and their derivatives, gelatin, syntheticpolymers, coatings and enterics, fillers and stearates.

Dehydrating agents or Desiccating Agents can include but are not limitedto sodium carboxy methyl cellulose, silica gel, microcrystallinecellulose, carboxymethylcellulose calcium, cellulose, colloidal siliconedioxide, and crosscarmellose Sodium.

TABLE VIIB DOSE PER BODY WEIGHT FOR CHILDREN (mg per kg) ComponentPreventative Broad Preferred Preferred Childrens Range Range AmountSubstitution Dosing mg/kg mg/kg mg/kg mg/kg Category ACTIVE INGREDIENTSartemisinin  5.67-13.61 10.21-12.47 approx 11.39 berberine  39.69-113.40 68.04-102.06 approx 90.72 BLEND    0-226.80 136.08-226.80 approx 158.76Excipient with MIXTURE* Active Ingredients INACTIVE INGREDIENTSpeppermint    0-31.75 15.88-31.75 approx 22.68 Flavoring xylitol   0-544.31 362.87-544.31 approx 453.60 Sweetener 83%    0-54.4336.29-54.43 approx 45.36 Masking maltodextrin Agent and 17% naturalflavors sucralose   0-5.44 3.63-5.44 approx 4.54 Sweetener INERT Forbinding or delivery of other ingredients INGREDIENTS silicon dioxide   0-99.79 72.57-99.79 approx 90.72 Water reducing agent that promotesabsorption of water and prevents caking or clumping calcium carbonate   0-544.31 362.87-544.31 approx 453.60 Inert filler precipitated silica   0-13.15 10.43-13.15 approx 12.09 Anticaking, free flow agent

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin andberberine in the amounts referenced in the above tables.

For children, defined as persons between the ages of 2 and 12 with abody weight below 110 pounds, the dosage is two tablets per day with ameal for 7 to 14 days depending on the number of days desired to stayparasite free. Two tablets provides 50 mg of artemisinin or one-half theadult dose. Tablets may be chewed or dissolved in the mouth. Twochewable tablets per day for 7 to 14 days is effective for preventinginfection for 30 to 60 days, respectively. In addition to preventingmalaria, the dosage regimen is appropriate for prevention of denguefever, dysentery and yellow fever.

A dosage of two capsules a day for 14-28 days is effective forpreventing Lyme disease and or babesiosis for 30 to 60 days,respectively.

Thus, someone skilled in the art makes a judicious selection of anappropriate dosage regimen; selection is dependent on the age or bodyweight of the patient, condition to be treated and the judiciousselection is not a limitation of the present invention.

Methods of Manufacturing Tablets, Pills and Capsules

Our product by design and claim states a “passively accurate dosingsystem.” Our manufacturing claims stated herein make it extremelypossible to maintain and honor those claims. However, one can neverpreclude the possibility of the existence of some variance when mixingpowdered compounds under high pressure. Although the FDA (stated in a2004 letter from Dr. Steven Galson, then director of the Center for DrugEvaluation and Research at the FDA and now U.S. Surgeon General, that−20/+25%, “actually represents the acceptable bounds on the 90%confidence intervals around the ratio of the mean result for products”)accepts those high deviations as normal, our concern was for tolerancesat those extreme limits. However, while we believe there to be areasonable amount of efficacy and safety at these extremes; we do notexpect to exceed plus or minus 5% of our stated ingredient values.

Before the two active ingredient raw materials are accepted by themanufacturing laboratory, a chemical analysis of the composition isperformed by an independent, third party commercial laboratory. Thisanalysis confirms the purity of the materials as well as other compoundsthat might be present in the shipment. Industry standards for purity andother compounds are known and used to accept or reject a shipment.

Once the product is manufactured but before it is packaged, random batchsamples are sent to another independent, third party commercial analysislaboratory where the pills are inspected and broken down to determinetheir contents. The dosing amounts are maintained as stated on thepackaging, and the pills must be free of any contaminants. Failure toobtain the analysis laboratory approval results in a rejection of thebatch.

In the Examples below, two types of compounds previously identified asanti-malarial agents are combined into one single pill. Artemisinin is aplant-based terpenoid compound that is known for use as an anti-malarialagent. Berberine is a plant-based alkaloid with a very bitter taste andwater content in a range of approximately 14 wt. %. Successful bondingand adhesion through use of non-active ingredients is essential in orderto produce a compressed physically stable pill. Adding granulation stepsto the process reduces water and subsequently reduces the amount ofnon-active ingredients or excipients needed.

In addition, the manufacturing process solves the problem of keeping theformulated pill from becoming hydrated during shipment and storage intropical climates by using blister packing immediately at the end ofprocessing to maintain chemical composition and stability.

Methods of making an adult tablet and a chewable tablet will bedescribed in examples 1 and 2 below.

Example 1 Method of Making an Adult Tablet

Calculate the weight for total production based on raw materials ofartemisinin and berberine that are combined in a weight ratio of 1:8 or100 mg of artemisinin to 800 mg of berberine.

In a V-Blender, mix the active ingredients, artemisinin and berberine ata low speed, i.e., 15 rpm, for 25 minutes to insure dispersal. Then addthe non-active ingredients to the V-Blender in the following order: 540mg microcrystalline cellulose, 40 mg silicon dioxide, 300 mg stearicacid, 1,000 mg calcium carbonate, 75 mg magnesium stearate, 40 mgcroscarmellose sodium and continue blending for an additional 20 to 30minutes.

Remove the mixture of active and non-active ingredients from the blenderand filter through a 20 mesh screen, followed by filtering through a 100mesh screen. After filtering through the 100 mesh screen, an oscillatinggranulator is used to granulate the mixture by feeding through a 45 rpmfeed screw onto roller compactor (knurled rollers: 200 mm×50 mm) rollersset on low speed (15 rpm). Production of chips is the desired physicalstate after granulation.

Feed the granulated mixture into a tablet press; set to 8 US tons ofpressure, at a speed of 900 rpm to produce tablets. Clean and vacuum thepills, so that no dust is present.

The cleaned and vacuumed pills are then placed in a coating machine(food grade pharmglaze). An enteric shell coating is applied. Coating iscritical as a barrier to re-hydration and resists changes due tohumidity found in the mostly equatorial destinations for the pills andtemperature fluctuations in air cargo shipments. The coating is criticalto preserving dosage integrity.

Following the coating of the pills, they are heated and tumbled at 45degrees C. for 30 minutes. The heated and tumbled pills are thanpackaged immediately (within 24 hours) in a blister pack that is knownin the art to prevent re-hydration and deterioration.

Example 2 Method of Making a Chewable Pill for Children

The method for making the adult tablet is used for making a chewablepill with the following adjustments to active and non-activeingredients. First, the active ingredients artemisinin and berberine arecombined in a weight ratio of 1:8 or 25 mg of artemisinin to 200 mg ofberberine. The non-active ingredients added to the blender includeflavorings and sweeteners and a masking agent to make the pill palatableso that ill children will chew and swallow the composition.

More specifically, in a V-Blender, the active ingredients, artemisininand berberine are blended at a low speed for 25 minutes to insuredispersal. Then the non-active ingredients are added to the V-Blender inthe following order: 50 mg peppermint flavoring, 1000 mg xylitol, 100 mgmasking agent (a mixture of 83% maltodextrin and 17% natural flavors),10 mg sucralose, 26.66 mg precipitated silica, 1000 mg calciumcarbonate, 200 mg silicon dioxide and continue blending for anadditional 20-30 minutes. Sucralose and xylitol are natural sweetenersthat do not raise blood sugar levels and add no caloric value.

The processing steps are the same as in Example 1 after removal of theactive and non-active ingredients from the V-Blender.

Prior to the present invention, it was not known to combine artemisininand berberine and in a single pill, tablet or capsule in the specificweight ratios disclosed. It was also not known that this combination ofactive ingredients could successfully treat and prevent infectiousdiseases such as, but not limited to, malaria, dengue fever, dysentery,yellow fever, Lyme disease, babesiosis, progressive multifocalleukoencephalopathy, Helicobacter Pylori, and colitis. It is alsosignificant that the formulation of the present invention contain noquinine or quinine derivatives. The artemisinin and berberinecompositions of the present invention can be expected to transformmedical care and dramatically reduce illness and death from infectiousdiseases and infection-causing bacterial strains that have developedresistance to antibiotics.

In addition to therapeutic benefits, the present invention solves theproblem of incorrect dosages by self-administering patients, inaccuratecombining of ACTs which leads to non-therapeutic results, and a chewableform of tablet or pill agreeable to children.

Table VIII shows pediatric doses shipped to foreign countries fortesting doses for various treatments as of Oct. 1, 2012.

TABLE VIII Shipped Quantity - Pediatric Doses Countries Cholera DengueMalaria Grand Total Ghana 100 100 Guatemala 25 25 Haiti 15 15 Honduras 55 Kenya 5 5 10 Liberia 2 19 21 Marshall Islands 5 5 Nicaragua 20 55 75Nigeria 100 2 102 Philippines 25 35 5 65 Puerto Rico 5 5 10 Thailand 5 5Togo 110 110 Zimbabwe 5 5 Grand Total 52 195 306 553

Table IX shows adult doses shipped to foreign countries for testingvarious treatments as of Oct. 1, 2012.

TABLE IX Shipped Quantity - Adult Doses Countries Cholera Dengue MalariaGrand Total Brunswick 20 20 Ghana 200 200 Guatemala 50 50 Haiti 25 25Honduras 10 5 15 Kenya 5 5 10 Liberia 2 34 36 Marshall Islands 15 15Nicaragua 320 110 430 Nigeria 200 2 202 Philippines 50 100 10 160 PuertoRico 50 10 10 70 Thailand 10 10 Togo 220 220 Zimbabwe 5 5 Grand Total157 715 596 1468

The various patients from Case Studies residing in the US are availablefor direct contact and verification

Malaria

A nongovernmental organization (NGO) asked the inventors if they couldbring malaria treatment samples with them on their mission trips. Weagreed with the understanding that if they used the samples, they wouldsend field reports back of their experiences. The following are thefield reports we received from Ghana:

Malaria Field Report #1

Patient's Name: Hodzinya R.

Date: 28 Jan., 2012

Age of patient: 40

DAY ONE of coACT A-B Malaria Therapy

two tabs in the morning and two in the evening were taken and the bittersaliva still persisted, but felt feverish for the greater part of theday and felt very weak

DAY TWO of coACT A-B Malaria Therapy

The same dosage and the feverish condition stopped and [the patient]started eating slowly, but the weakness was reported

DAY THREE of coACT A-B Malaria Therapy

One tablet in the morning. The weakness was gone and bitter saliva alsowas gone.

DAY FOUR OF coACT A-B Malaria Therapy

The last tablet was taken in the morning and the heat and feverishcondition were gone. Appetite regained.

Malaria Field Report #2

Patient's Name: Angela A.

Date: 28 Jan., 2012

Age of patient: 24

DAY ONE of coACT A-B Malaria Therapy

two tabs in the morning and two in the evening were taken and the bittersaliva still persisted, but felt feverish and could not drink water

DAY TWO of coACT A-B Malaria Therapy

The same dosage and the feverish condition stopped and started drinkingslowly, but the weakness was reported. She was not feeling comfortablein her stomach

DAY THREE of coACT A-B Malaria Therapy

One tablet in the morning. The weakness was gone, stomach upset gone,and bitter saliva also was gone.

DAY FOUR of coACT A-B Malaria Therapy

The last tablet was taken in the morning and the heat and feverishcondition were gone. Appetite regained for both water and food.

Malaria Field Report #3

Patient's Name: Prosper A.

Date: 28 Jan., 2012

Age of patient: 36

DAY ONE of coACT A-B Malaria Therapy

two tabs in the morning and two in the evening were taken and the bittersaliva still persisted, but he felt feverish and could not eat/drinkwater

DAY TWO of coACT A-B Malaria Therapy

The same dosage and the feverish condition subsided and started drinkingslowly. He was not feeling very well then

DAY THREE of coACT A-B Malaria Therapy

One tablet in the morning. The feverish condition was gone, feelingquite well, and bitter saliva also was gone.

DAY FOUR of coACT A-B Malaria Therapy

The last tablet was taken in the morning and the heat was gone. Appetiteregained. For both water and food.

Malaria Field Report #4

Patient's Name: Mawusi A.

Date: 28 Jan., 2012

Age of patient: 28

DAY ONE of coACT A-B Malaria Therapy

two tabs in the morning and two in the evening were taken but the bittersaliva still persisted, and she felt feverish and loss of appetite

DAY TWO of coACT A-B Malaria Therapy

The same dosage and the feverish condition subsided and appetite wasrestored. The heat persisted

DAY THREE of coACT A-B Malaria Therapy

One tablet in the morning. The feverish condition was gone, the heat wasgone, feeling quite well, and bitter saliva also was gone.

DAY FOUR of coACT A-B Malaria Therapy

The last tablet was taken in the morning and the heat was gone. Appetiteregained for both water and food. She lost some weight

Malaria Field Report #5

Patient's Name: Davigah D.

Today's Date: 28 Jan., 2012

Age of patient: 40

DAY ONE of coACT A-B Malaria Therapy

two tabs in the morning and two in the evening were taken and the bittersaliva was tamed, but she felt feverish for the greater part of the dayand felt dizzy

DAY TWO of coACT A-B Malaria Therapy

The same dosage and she somehow regained appetite and started eatingslowly, but the knees were shaking.

DAY THREE of coACT A-B Malaria Therapy

One tablet in the morning. The dizziness was gone and also the shaking

DAY FOUR of coACT A-B Malaria Therapy

The last tablet was taken in the morning and the heat was gone and shewas able to drink enough water and ate quite well.

Case studies for dengue fever, Lyme disease, Helicobacter Pylori (HP),colitis will now be described.

Dengue Case Study #1

21-year-old young lady named Carla, who works as a nurse at a localclinic. Carla was diagnosed with Dengue through confirmation of a urinetest and a blood test. She was in terrible pain and vomiting when herfever elevated, which hovered over 102 degrees Fahrenheit. This went onfor several days until she took her first day's treatment of coACT A-Bfor Dengue Fever. Within one day, her vomiting had stopped, but moreimportantly, the crippling pain that ran through her body had alsosubsided. Carla was needed back at work, but still feeling tired. Hersecond day's treatment brought brighter results and she began to feellike herself again with all symptoms gone.

Lyme Disease—Case Study #1

Shawn F. is a 48-year-old Caucasian female, who is 5′4″ and weighs 200lbs. She is a full-time registered nurse, and lives in the UnitedStates. Her first symptoms appeared in September of 2008. When Shawn wasfirst diagnosed with Lyme disease she had the tell-tale “target” lesionand was prescribed 10 days of the antibiotic doxycycline. She wasdiagnosed by her husband (a full-time practicing Physician's Assistant)and herself. Her disease progressed to Stage 2 Lyme due to inadequateStage 1 treatment. Her doctors did not diagnose Stage 2 because she hadbeen given antibiotics during the initial stage, and they believed thatwould rid her of Lyme disease. However, her doctors soon observedblindness, arthritis, and severe photophobia. Shawn was examined by 14different specialists, in part because of her occupation in the healthcare industry; her physicians included internists, infectious diseasespecialists, tropical diseases specialists, and others.

After many diagnoses and treatments that did not assuage her symptoms,Shawn was desperately searching for something to ease her constant painand disability. Unfortunately, she had been misdiagnosed so many timesthat the disease had time to spread throughout her body, furtherprogressing to becoming tertiary and causing severe pain, debilitatingmigraines, and near-total vision loss. Shawn could no longer practicenursing. She was confined to her home; hers was a dark, shutteredexistence, since exposure to even the slightest light triggered severemigraines. Depression and thoughts of suicide plagued her. It was atthis point that she took her first dosage of coACT A-B; immediately herarthritis and photophobia improved but the blindness remained. Shemaintained a Lyme diet, followed the dosing as written, was not takingany other medications intended for Lyme disease, and experienced no sideeffects. Shawn has since returned to practicing nursing again, andcredits coACT A-B with much of her recovery.

Case Study #2—Lyme Disease

Kathy T. is a 41-year-old Caucasian female, who is 5′1″ and weighs 153lbs. She worked as a full-time project manager for a non-profit foodbank, and lives in the United States. Her symptoms first appeared inAugust of 2010. When Kathy was first diagnosed she had skin rashes thatwere not helped with topical treatments, low-grade fevers, severemigraines, continuous muscle aches, sore throat, stomach pain, jointpains, gynecological issues, and constant fatigue. The initialindication was hives on her stomach and back which grew to circularrashes on both thighs, all directly following an insect bite from whatshe believes to have been a horse fly.

Kathy sought and received treatment from a gynecologist, anacupuncturist, a primary care physician, a chiropractor, a massagetherapist, two neurologists, a rheumatologist, an ENT, a nursepractitioner, and a naturopath. From these professionals she wasdiagnosed not only with Lyme disease, but the following diagnoses and/ormisdiagnoses: fibromyalgia, depression, arthritis, pinched nerve,burning mouth syndrome, and mycotoxic poisoning. By May 2011 she wasconfirmed with Lyme disease and subsequently reconfirmed by anotherphysician in August 2011. Her case of Lyme disease was clinicallydiagnosed based on lab findings, Western Blot, and symptomatology. Kathyfurther tested positive for Ehrlichia via Igenix lab test, as well as onLyme tithers 41, 23, and 39, Epstein Barr, Parvo, M. Pnemoniae, HHV 6,and Cytomegalovirus (common co-infections of Lyme), and high C4a andCD57 numbers. Kathy was initially prescribed a 45-day regimen ofDoxycycline, which helped eliminate her then inability to talk and walk.Additionally, she was given Nystatin and vitamins, neither of which madeany detectable difference. Acyclovir caused her symptoms to worsen inthat she could not lift her arms. GU treatment (Chinese herbs) helpedher for a couple of months and then stopped working. Ivermectin andPyrantal Pamoate helped her to pass parasites in her stool, but left herlifeless, dizzy, and with nystagmus. Intravenous Rocephin administeredthree times per week for four weeks helped restore her energy, butcaused an allergic reaction. Tindamax was likewise not tolerated.Albendazole seemed to help her with passing parasites. Otheranti-fungals caused pain and further reduced her energy levels.

Kathy was taking Albendazole during the initial phase of her coACT A-Bdosing, and she followed the dosing that was given to her in April of2012. Her side effects (muscle tremors at night) dissipated within thefirst week of dosing. Kathy experienced a significant increase in energyand stamina, which improved her overall condition in ways she had notexperienced since contracting Lyme disease. She reported climbing thelighthouse stairs in St. Augustine, Fla. without suffering a decrease inenergy afterwards, which was atypical for her at that time. She reportedwaking up early, and feeling refreshed, which she said was far from thenorm for her; since she was not taking any other medications at thetime, she attributes it entirely to coACT A-B. Her arthritic arm painhad also diminished significantly within four days of taking coACT A-B;she described the pain in her arms as having gone from a high of 7-8 onthe pain scale to a low of 1-2. She also reported passing some oddsnail-like items in her stool, which in itself was not unusual for her,but she believes that these were different, almost slug-like, and Kathystated that afterwards she felt as though she had expelled “somethingpoisonous.” Upon further exams and testing, her HHV-6 had dropped from25.38 to 4.8, producing the first positive change Kathy had seen in anyof her virus lab tests during the past two years. Kathy has stated thatcoACT provided her with “a few really good weeks which is invaluablewhen you haven't functioned normally for some time. For chroniclong-term patients, I suspect additional dosing (like every few monthsor so) is necessary. For newcomers or uncomplicated cases, it could be abridge to health and healing.

Lyme Disease—Focus Group Survey Results

Subsequent results based on Focus Group responses from a group of 18Lyme patients taking the dosing over a 24 day period.

FIG. 1 is a graph of a Lyme focus group survey results for ratingquality of life. This shows periods of improvement in the quality oflife during both dosing phases and regression during the period of nodosing.

FIG. 2 is a graph of Lyme focus group survey results requestingparticipants to rate how easy it is to bend, kneel or stoop. This showsan 28% improvement in leg mobility throughout the dosing schedule.

FIG. 3 is a Lyme focus group survey results for rating everydayactivities. This shows fluctuations in improvement for activities ofdaily living. The trend overall from beginning to end of dosing shows17% improvement.

FIG. 4 is a Lyme focus group survey results for rating vigorousactivities. This shows moderate improvement in strenuous activities.This is the category that started with the lowest baseline, so theoverall improvement of 25.7% was significant.

FIG. 5 is a Lyme focus group survey results for rating bath, shower anddress capability. This shows 13.2% improvement in ability to bathe anddress.

FIG. 6 is a Lyme focus group survey results for rating appetite and foodconsumption. This shows 13.9% improvement in appetite and ability toconsume food.

FIG. 7 is a Lyme focus group survey results for rating intake of fluids.This generally shows minimal impact on ability to consume fluids. 2.5%improvement is not statistically significant Testing Procedures todetermine the Pill.

FIG. 8 is a Lyme focus group survey results for rating ability to moveand turn neck. This shows some early improvement during the first weekof dosing, with some regression in progress but overall 8.8% improvementfrom baseline.

FIG. 9 is a Lyme focus group survey results for rating ability to situpright and do activities. This shows some moderate improvement towardsthe end of the dosing schedule in ability to sit while performing dailyactivities. Overall improvement is 5%.

FIG. 10 is a Lyme focus group survey results for rating sensitivity tolight. Light sensitivity is a common issue for Lyme patients. Thisshowed an overall 20 improvement in sensitivity to light.

FIG. 11 is a Lyme focus group survey results for rating sensitivity tosound. Overall improvement in sensitivity to sound 15.9%

FIG. 12 is a Lyme focus group survey results for rating overall level ofjoint pain. Joint pain may be caused by accumulation of deadspirochetes. Overall improvement in joint pain was 13.3%

FIG. 13 is a Lyme focus group survey results for rating overall mood.This was one of the most significant areas reported for improvement.Overall mood improved 23.6% during the course of the dosing.

Helicobacter Pylori (HP) Case Report #1

Melissa D. is a 61-year-old Caucasian female, who is 4′11″ and weighs147 lbs. She is an antiques and collectibles dealer, selling full timein a store location as well as on-line, and lives in the United States.Melissa's first symptoms appeared when she was in her late 20's; at thattime she was diagnosed with a duodenal ulcer. Shortly after whatappeared to be a successful recovery, a deep tissue biopsy in 1989revealed that she suffered from systemic lupus. She was treated withsteroids but did not tolerate them very well. A program was developedthat included Shark Cartilage, Fish Oil, and DHEA; Melissa followed thisprogram successfully and the lupus went into remission within threemonths. Decades later, she continues to maintain her diet and intake ofthe three supplements in order to keep the lupus in check.

Her first diagnosis of Helicobacter Pylori was in the 1990's, and hertreatment has included Proton Pump Inhibitors (PPI), as well as Choline,Inositol, Serrapeptase, and Hesperidin, as well as monitoring her diet,but not in according to any regular schedule. She continues to bemonitored and cared for by two physicians, an MD and a DO, who both giveher a poor prognosis of leading a normal life in terms of digestivehealth. She is frequently deprived of energy, lacks stamina to performdaily household chores, and is always anxious regarding access tobathroom facilities when she is in an unfamiliar location.

Melissa was prescribed several PPI's, but finds their effectivenessdiminishing with each successive administration. She tries to maintain asense of normalcy by restricting her diet, reducing stress where shecan, and undertaking a modest exercise program. She suffers from acuteHP almost once a week in spite of her efforts.

Before her coACT A-B trial began, Melissa stopped taking any othermedications or supplements for a full week. By the second day of dosingMelissa experienced more vigor and better sleep than she had in manyyears. She went off her diet (because she felt absolutely no twinges orsignals of an impending attack), eating as she pleased for the firsttime in several years. Her diet became totally contradictory to what hasbeen advised and prescribed to her, and included such risky fare asfried chicken, store-made tacos, and chocolate. Normally any one ofthese foods would trigger a severe attack; however, Melissa states shehas not experienced a single attack since she began taking coACT A-B.Melissa's dosing regimen followed an alternative “pulse” plan that werecommended to her. She took two pills a day for Days One and Two,followed by one pill a day for eight more days. This was followed by an“off” period of 8 days where she took no coACT A-B at all, which wasthen followed by eight more days of taking one coACT A-B tablet per day.This trial was September of 2012. Melissa has, as of this date offiling, not experienced another acute attack of HP; in fact, she doesnot sense any of her previous symptoms. She did not note any sideeffects during his trial or in the time thereafter that we havecollected her follow up data (October 2012).

Colitis Case Report #1

Jim G. is a 60-year-old Caucasian male, who is 5′11″ and weighs 212 lbs.He is a full-time logistics professional who lives in the United States.Jim's first symptoms appeared in June 2001, following an overseas tripto Vietnam. While in Vietnam, Jim became seriously ill and was unable tocontinue the scheduled trip, returning immediately to the United States.His family doctor examined him and sent him to a gastroenterologist who,after performing several tests, diagnosed Jim's illness as Campylobacterjejuni. Since that time Jim has suffered violent stomach cramps, usuallywith no advance warning. Subsequent to that first event, and uponadditional clinical examinations and testing by his physician, includingstool samples, blood tests, and a colonoscopy, Jim has been diagnosedwith mild colitis.

Jim was prescribed aminosalicylates and steroids by his doctor; bothmedications are in pill form, with a dosage of four pills to be takenthree times daily. Jim found that he could not tolerate either of thetwo prescriptions, which often left him with as much pain as the colitisitself caused. For the past eight years Jim has elected not to takeprescription drugs to treat his colitis, instead submitting to andaccepting the attacks of colitis which occurred, on average, once amonth.

During his coACT A-B trial, Jim was not taking any medicine for colitis,nor was he taking any other digestive aid. Jim began his trial of coACTA-B while suffering from a colitis attack; he was experiencing severeacute stomach pain before he took his first dose. After the first doseJim felt some relief and by the second day, his acute stomach pain wasrelieved. Jim followed the dosing on the package (two pills a day forDay One and Day Two, followed by one pill a day for eight days) andremained on the treatment for a full 10 days. This episode was inmid-January, 2012. As of this date of filing, Jim has not experiencedanother attack of colitis. He did not note any side effects during histrial or in the time thereafter that we have collected his follow-updata (October 2012).

Colitis Case Report #2

Angie L. is a 43 year old Caucasian female, who is 5′6″ and weighs 185lbs. She is an information technology professional with her own company,and lives in the United States. Her first symptoms appeared in her earlyteens with bouts of diarrhea; these began as random bouts at age 13,becoming increasingly frequent until by the age of 16 they were nearly adaily occurrence. Her parents brought her to a pediatrician, whorecommended dietary changes. She began by eliminating chocolate, thensugar, then soft drinks, then caffeine in both liquids and solids. Afteradditional examinations and counseling, the pediatrician attributed hercondition to stress, describing it as a “nervous stomach.” When Angiewas 16, the pediatrician referred her to a gastroenterologist, as Angiewas missing days of school more frequently as the bouts of diarrhea wereworsening. She was given a colonoscopy; the results were relativelynormal, and no polyps were found. She was prescribed Bentyl withinstructions to use when acute attacks presented. At age 25, Angie wasprescribed a series of tests by Dr. Keith Moore of Orlando, includingcolonoscopy and endoscopy, resulting in diagnoses of collagenous colitisand a duodenal ulcer. Since cases of this type of colitis wereconsidered rare, a second opinion was obtained at the University ofFlorida Shands Hospital. There, the initial diagnosis was confirmedfollowing a colonoscopy, endoscopy and additional extensive digestivetract testing.

Angie was prescribed drugs designed and intended to lower cholesterol;these medications were known to be effective in slowing down the effectsof chronic diarrhea. She then switched to Asacol and Prevacid forseveral years, which was followed by Prevacid and other ulcerprescriptions. She did not tolerate many of the prescriptions well, asthey usually resulted in severe stomach cramps. In 2001, Angie begantaking Ultram to combat the mild arthritis and joint pain associatedwith the colitis, and the drug's side effects helped to curtail the painfor a few years. She was able to completely drop ulcer medications in2003 and began taking Hyoscamine daily for the colitis.

After the Hyoscamine's effectiveness decreased, early in 2012, she begana course of coACT A-B. After taking two coACT A-B tablets a day for daysone and two, she halved the dosage for the following eight days(one-half of a coACT tablet per day). She did experience stomach crampsand a “burning sensation” while taking coACT A-B, which she attributedto her ulcer. Angie's condition, since the age of 13, has alwaysentailed 10 trips a day to the bathroom, and chronic diarrhea. At age42, having taken coACT A-B, Angie reports that she now experiencesnormal BMs for the first time in nearly 30 years. Her colitis continuesto present itself but she feels that her present condition, since takingcoACT A-B, is better than anything she has experienced since the age of13. Her bloating and cramping has steadily diminished, as has hersensitivity to certain foods. Since January 2012, when she began takingcoACT A-B, to the date of this application (October 2012), Angie has nolonger needed any daily medication.

Dengue Fever Results

Dr. Jamie Z. Galvez Tan MD, MPH, former Vice Chancellor for ResearchUniversity of the Philippines and a known expert in the field, testedthe efficacy of the invention combination of artemisinin and berberinefor treating Dengue Fever. On Oct. 7, 2012, Dr. Galvez reported that “Iam pleased to inform you of my staff's and my initial findings using theinitial 200 sample doses you provided of coACT A-B Dengue Fever Formula.We have observed that coACT A-B is highly effective in relieving thesymptoms of dengue fever patients, based on both clinical physicalexaminations and clinical measurements. We witnessed a uniform return towellness—the ability to drink and increase in appetite, as well asdesirable changes in patients' blood platelet levels—in as little aseight hours after the initial dosing. These results appear to indicateaction against all four types of dengue fever.”

Although the embodiments above describe the combination of artemisinineand berberine, the invention can include combinations of the derivativesof artemisinin with berberine. The deriviatives of artemisinin caninclude but are not limited to: artesunate, artemether,dihydroartemisinin, artelinic acid, artenimol, and artemotil. Forexample, the chemical weight of artesunate can be adjusted to give thesame effective chemical yield as artemisinin, and artesnuante andberberine can then combined. Similarly, the chemical weight ofartemether can be adjusted and combined with berberine.

Similarly, the chemical weight of dihydroartemisinin can be adjusted andcombined with berberine. Similarly, the chemical weight of artelinicacid can be adjusted and combined with berberine. Similarly, thechemical weight of artenimol can be adjusted and combined withberberine. Similarly, the chemical weight of artemotil can be adjustedand combined with berberine.

Alternative ACT with Natural Botanical Active Ingredients for Treatmentand Prevention of Chikungunva.

Chikungunya is a viral disease transmitted to humans by the bite ofinfected Aedes Aegypti mosquitoes. Chikungunya virus is a member of thegenus Alphavirus, in the family Togaviridae. Other notable vector-bornealphaviruses in the United States primarily includes Eastern equineencephalitis virus and also to a much lesser extent, Western equineencephalitis virus. Chikungunya virus was first isolated from the bloodof a febrile patient in Tanzania in 1953, and has since been identifiedrepeatedly in West, Central and Southern Africa and many areas of Asia,and has been cited as the cause of numerous human epidemics in thoseareas since that time. The virus circulates throughout much of Africa,with transmission thought to occur mainly between mosquitoes andmonkeys. Chikungunya has been described by both patients and attendingphysicians as a “cousin to malaria.”

Although first isolated in Tanzania in 1952, it wasn't until morerecently in 2004, that chikungunya virus spread throughout the largerportion of Africa and into the Central Asian Continent and SoutheastAsia often causing large and sporadic epidemics in those regions.

The name “Chikungunya” is derived from the language of the Makondeethnic groups in southeast Africa and means “that which bends” or“stooped walk.” This is in reference to the hunched over appearance ofindividuals who are infected due to the characteristically painful andoften times incapacitating arthralgia caused by the virus.

Until recently, chikungunya virus was primarily sequestered to Africa,Asia, and the Pacific islands. The first locally transmitted case in theWestern Hemisphere, meaning that the index patient had not traveled to achikungunya virus endemic region, occurred in December of 2013 on theisland of St. Martin.

As of June 2014, over 165,000 suspected cases of chikungunya virusinfection in the Western Hemisphere have been reported, of which over4,500 have been confirmed by laboratory testing and these numbers arecontinuing to increase.

Importantly, indigenous or local transmission of chikungunya virus hasnot been reported in the United States or its territories, aside fromPuerto Rico. And as of June 2014, the 57 reported US cases have thus farbeen associated with travel to endemic areas.

However, due to the widespread distribution of a competent mosquitovector in the United States and a naïve host population that has not yetbeen exposed to and lacks protective immunity to chikungunya virus, thepossibility of chikungunya virus outbreaks in the United States is avery real public health threat.

Clinical Presentation:

Following transmission of the virus by the bite of an infected mosquito,the incubation period, prior to development of symptoms, ranges onaverage from 3 to 7 days. Unlike other mosquito-borne viruses like WestNile virus and dengue virus, the majority of individuals who are exposedto chikungunya virus become symptomatic, with the most severemanifestations observed at the extremes of age and in those withsuppressed immunity. Importantly, however, it was once believed thatexposure to chikungunya virus would allow individuals to develop lastingimmunity and protection from re-infection. That belief is no longer heldby the modern view, evidence of such as by what is currently beingexperienced in other Countries.

Also, fatalities due to chikungunya virus infection are uncommon, thoughthey have been reported among elderly patients with significantunderlying comorbidities or those with suppressed immune function.

Chikungunya virus infection can progress through 3 distinct stages, theacute, subacute, and chronic forms.

During the acute stage of infection, most individuals will experience asudden onset, high fever along with severe and often incapacitatingjoint pain or polyarthralgia. The polyarthralgia is typically bilateraland symmetric, involving multiple joints, most commonly in the hands andfeet. A fair percentage of patients will also present with amaculopapular rash involving the trunk and extremities that develops 2to 5 days following fever onset.

Other less common symptoms include severe headache, myalgias, and backpain, and laboratory findings are fairly nonspecific, includingthrombocytopenia, leukopenia, and elevated liver function tests. Thisstage of infection can last anywhere from 3 to 10 days, after which mostpatients will feel significant symptom relief and improvement.

The majority of people infected with chikungunya virus becomesymptomatic. The incubation period is typically 3-7 days (range, 1-12days). The disease is most often characterized by acute onset of fever(typically >39° C. [102° F.]) and polyarthralgia. Joint symptoms areusually bilateral and symmetric, and can be severe and debilitating.Other symptoms may include headache, myalgia, arthritis, conjunctivitis,nausea/vomiting, or maculopapular rash. Clinical laboratory findings caninclude lymphopenia, thrombocytopenia, elevated creatinine, and elevatedhepatic transaminases.

As stated previously, unfortunately, symptom relapse can occur in someindividuals, most often reappearing 2 to 3 months following the initialinfection. This is defined as the subacute stage and patients primarilyexperience rheumatic symptoms including exacerbation of pain inpreviously affected joints.

While most individuals will recover from the acute or subacute stages,for some patients, symptoms can persist for months to years followinginitial infection, leading to chronic rheumatism and fatigue. In studiesfrom Africa and India, the percentage of individuals with chronicsymptoms at 10 months postinfection varies from 12 to 50% with theelderly at greatest risk.

Acute symptoms typically resolve within 7-10 days. Rare complicationsinclude uveitis, retinitis, myocarditis, hepatitis, nephritis, bullousskin lesions, hemorrhage, meningoencephalitis, myelitis, Guillain-Barrésyndrome, and cranial nerve palsies. Persons at risk for severe diseaseinclude neonates exposed intrapartum, older adults (e.g., >65 years),and persons with underlying medical conditions (e.g., hypertension,diabetes, or cardiovascular disease). Some patients might have relapseof rheumatologic symptoms (e.g., polyarthralgia, polyarthritis,tenosynovitis) in the months following acute illness. Studies reportvariable proportions of patients with persistent joint pains for monthsto years. Mortality is rare and occurs mostly in older adults.

Transmission:

Chikungunya virus is primarily transmitted to humans through the bitesof infected mosquitoes, predominantly Aedes aegypti and Aedesalbopictus. Humans are the primary host of chikungunya virus duringepidemic periods. Blood-borne transmission is possible; cases have beendocumented among laboratory personnel handling infected blood and ahealth care worker drawing blood from an infected patient. Rare in uterotransmission has been documented mostly during the second trimester.Intrapartum transmission has also been documented when the mother wasviremic around the time of delivery. Studies have not found chikungunyavirus in breast milk and there have been no reports to date of infantsacquiring chikungunya virus infection through breastfeeding. Because thebenefits of breastfeeding likely outweigh the risk of chikungunya virusinfection in breastfeeding infants, mothers should be encouraged tobreastfeed even if they are infected with chikungunya virus or live inan area with ongoing virus transmission.

The risk of a person transmitting the virus to a biting mosquito orthrough blood is highest when the patient is viremic during the firstweek of illness.

Regarding transmission, it's important to remember that humans are theprimary reservoir for chikungunya virus and that Aedes species mosquitosare the primary vectors, with the viral life-cycle circling betweenthese 2 hosts. Aedes albopictus and Aedes aegypti are the 2 mainmosquito species competent for transmission of chikungunya virus and arealso responsible for transmission of dengue virus, another emergingvector-borne illness. Aedes mosquitos are notorious daytime biters andbetween the 2 Aedes species, Aedes albopictus can survive at moretemperate latitudes and is therefore more widespread throughout theSoutheast United States.

Other less commonly reported routes of infection, which have primarilybeen documented in regions endemic for chikungunya virus, includebloodborne transmission through needle sticks and in utero transmission,most often occurring during the antepartum period of pregnancy.

Mosquitoes become infected when they feed on a person infected withchikungunya virus. Monkeys, and possibly other wild animals, may alsoserve as reservoirs of the virus. Infected mosquitoes can then spreadthe virus to other humans when they bite. Aedes aegypti (also known asthe yellow fever mosquito), a household container breeder and aggressivedaytime biter which is attracted to humans, is the primary vector ofchikungunya virus to humans. Aedes albopictus (also known as the Asiantiger mosquito) may also play a role in human transmission in Asia, andvarious forest-dwelling mosquito species in Africa have been found to beinfected with the virus.

Diagnosis and Public Reporting, Chikungunya virus infection should beconsidered in patients with acute onset of fever and polyarthralgia,especially travelers who recently returned from areas with known virustransmission. The differential diagnosis of chikungunya virus infectionvaries based on place of residence, travel history, and exposures.Dengue and chikungunya viruses are transmitted by the same mosquitoesand have similar clinical features. The two viruses can circulate in thesame area and can cause occasional co-infections in the same patient.Chikungunya virus infection is more likely to cause high fever, severearthralgia, arthritis, rash, and lymphopenia, while dengue virusinfection is more likely to cause neutropenia, thrombocytopenia,hemorrhage, shock, and death. It is important to rule out dengue virusinfection because proper clinical management of dengue can improveoutcome. In addition to dengue, other considerations includeleptospirosis, malaria, rickettsia, group. A streptococcus, rubella,measles, parvovirus, enteroviruses, adenovirus, other alphavirusinfections (e.g., Mayaro, Ross River, Barmah Forest, O′nyong-nyong, andSindbis viruses), post-infections arthritis, and rheumatologicconditions.

Preliminary diagnosis is based on the patient's clinical features,places and dates of travel, and activities. Laboratory diagnosis isgenerally accomplished by testing serum or plasma to detect virus, viralnucleic acid, or virus-specific immunoglobulin M and neutralizingantibodies.

Chikungunya virus disease is a nationally notifiable condition.Healthcare providers are encouraged to report suspected chikungunyacases to their state or local health department to facilitate diagnosisand mitigate the risk of local transmission.

Treatment:

There are no specific treatments for chikungunya. There is no vaccinecurrently available. Chikungunya is treated symptomatically, usuallywith bed rest, fluids, and medicines to relieve symptoms of fever andaching such as ibuprofen, naproxen, acetaminophen, or paracetamol.Aspirin should be avoided. Infected persons should be protected fromfurther mosquito exposure during the first few days of the illness sothey can not contribute to the transmission cycle.

As with the majority of mosquito-borne viral infections, there is nospecific antiviral treatment for chikungunya virus. However, it isimportant to exclude other, more serious infections for which there istargeted treatment or alternative clinical interventions available,including malaria and dengue virus, respectively.

Treatment of patients with chikungunya virus infection is entirelysupportive, resigned to rest, fluids, and pain and fever management.Individuals who have persistent joint pain may require additionalsupportive care including corticosteroids and/or physiotherapy.

Unfortunately, Chloroquine is gaining ground as a possible treatment forthe symptoms associated with chikungunya, and as an anti-inflammatoryagent to combat the arthritis associated with chikungunya virus. AUniversity of Malaya study found that for arthritis-like symptoms thatare not relieved by aspirin and non-steroidal anti-inflammatory drugs(NSAID), chloroquine phosphate (250 mg/day) has given promising results.There is a debate about the appropriateness of chloroquine as treatmentfor chikungunya. Unpublished studies in cell culture and monkeys show noeffect of chloroquine treatment on reduction of chikungunya disease.

As in our prior U.S. patent application Ser. No. 13/660,553 filed Oct.25, 2012, now U.S. Pat. No. 9,011,892, which claims the benefit ofpriority to U.S. Provisional Patent Application Ser. No. 61/550,969filed Oct. 25, 2012, we had demonstrated and listed ad nauseam the illside effects, psychological and physical dangers of using Quinine andit's many derivatives. Once again (primarily due to it's low cost,remaining high stock counts, and the wrongful but familiar use for manyyears), we seem to be content traveling down that dark path once again.

In summary, chikungunya virus is an emerging, vector-borne threat to theAmericas, including the United States where we have both a large naïvehost population and widespread distribution of transmission competentAedes species mosquitos.

Infection with chikungunya virus is typically severe presenting withhigh fever, polyarthralgia, and often a maculopapular rash. Diagnosis isbased on clinical suspicion supported by serologic findings and/or PCRand, unfortunately, care is largely supportive only.

Table XA shows a table for the preventative composition for adults in mgper pill, and the dosing required, for the treatment of chikungunya:

TABLE XA Preventative Composition for Adults in mg per pill (2 capsules= 1 dosing configuration) Component Preventative Adult Dosing BroadPreferred Preferred Substitution [mg/Pill] Range Range Amount CategoryACTIVE INGREDIENTS artemisinin  25-60 mg  45-55 mg approx 50 mgberberine 175-500 mg 300-450 mg approx 400 mg capsaicin 150-300 mg200-275 mg approx 225 mg Papaya  20-80 mg  30-50 mg approx 60 mg Leafextract The following two categories (Blended Mixture and Inertingredients) are only used when making a compressed pill BLENDED  0-500mg 300-500 mg approx 350 mg Excipient MIXTURE* with Active IngredientsINERT For binding or delivery of other ingredients. INGREDIENTSmicrocrystalline  0-650 400-650 approx 540 Binders and cellulosecompaction stearic acid  0-200 200-400 approx 300 Lubricant excipientsilicon dioxide  0-50 30-50 approx 40 Water reducing agent and topromote absorption of water and prevent caking and clumping calciumcarbonate   0-1100  800-1100 approx 1000 Inert filler magnesium stearate 0-90 60-90 approx 75 For lubricating properties and to prevent powderedcomponent from sticking to the pill press equipment during thecompression from powder into solid tablets croscarmellose  0-50 35-50approx 40 To reduce sodium water solubility and allow the material toexpand, absorbing many times its weight in water and removing much ofthe water from Berberine.

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin,berberine, capsaicin, and papaya extract in the amounts referenced inthe above tables.

The inert ingredients are not therapeutic and are designed for theintegrity, palatability and stability of the tablets. There are manysubstitutes for the various classes of inert ingredients that caninclude disintegrants, lubricants, binders and excipients.

Disintegrants can include but are not limited to guar gums, ion exchangeresins, gums, micro-crystalline cellulose, aginates, cellulose,starches, sodium starch glycolate, cross povidone, gum karaya, chitinand chitosan, smecta, gullan gums, isapghula husk, polacrillanpotassium, and agar.

Lubricants can include but are not limited to stearic acid, magnesiumstearate, silica, hydrogenated vegetable oil, mineral oil, polyethyleneglycol, glyceryl palmitostearate, glyceryl bahenate, sodium benzoate,sodium stearyl fumarate, talc, and silicon dioxide.

Binders can include but are not limited to acacia, alginic acid,aluminum hydroxide, calcium hydroxide, calcium oxide, carboxymethylcellulose, cellulose, ethyl cellulose, gelatin, guar gum, maltodextrin,methyl cellulose, polyethylene glycol, and povidone.

Excipients can include but are not limited to flavorings, cellulosederivatives, calcium carbonate, magnesium stearate, silicon dioxide,masking agents, saccharides and their derivatives, gelatin, syntheticpolymers, coatings and enterics, fillers and stearates.

Dehydrating Agents or Desiccating Agents can include but are not limitedto sodium carboxy methyl cellulose, silica gel, microcrystallinecellulose, carboxymethylcellulose calcium, cellulose, colloidal siliconedioxide, and crosscarmellose sodium.

*The blended mixture referenced can include a blended mixtureapproximately 400 mg of concentrate of black walnut (Juglans nigra) dryouter hull; approximately 500 mg of concentrate of organically grownwormwood (Artemisia absinthium) dry flower and leaf; approximately 150mg of concentrate of Clove (Syzygium aronalicum) dry flower; andapproximately 700 mg of fresh leaf organically grown Chinese wormwood(Artemisia annua).

The concentrate of black walnut is an astringent that supports theintestinal system. Organically grown wormwood is used to improveappetite, aid in digestive functions, and assist in the absorption ofnutrients. The concentrate of Clove is a carminative, to increasehydrochloric acid in the stomach and to improve peristalsis. Chinesewormwood is used to reduce and stop fever.

For adults, defined as persons with a body weight of at least 110pounds, two capsules per day with a meal is taken for 7 to 14 daysdepending on the number of days desired to stay parasite free. Twocapsules per day for 7 to 14 days is effective for preventing infectionfor 30 to 60 days, respectively.

Table XB covers a dose per body weight (in mg per kg) for customizingdosages for adults less than or greater than 180 pounds (81.65 kgs), forthe treatment of chikungunya:

TABLE XB DOSE PER BODY WEIGHT FOR ADULTS (mg per kg) ComponentPreventative Broad Preferred Preferred Substitution Adult Dosing RangeRange Amount Category [mg/kg] mg/kg mg/kg mg/kg mg/kg ACTIVE INGREDIENTSartemisinin 22.68-54.43 40.82-49.89 approx 45.36 berberine 158.76-453.60272.15-408.23 approx 362.87 Capsaicin  68.18-136.36  90.91-125.00 102.27Papaya Leaf  9.09-36.36 13.64-22.73 27.27 Extract THE TWO CATEGORIESBELOW ARE USED ONLY IF MAKING COMPRESSED PILL BLENDED    0-226.80136.08-226.80 approx 158.76 Excipient with MIXTURE* Active IngredientsINERT For binding or delivery of other ingredients. INGREDIENTSmicrocrystalline    0-294.83 181.94-294.83 approx 244.94 Binders andcellulose compaction stearic acid    0-181.44  90.72-181.44 approx136.08 Lubricant excipient silicon dioxide    0-22.68 13.61-22.68 approx18.14 Water reducing agent and to promote absorption of water andprevent caking and clumping calcium carbonate    0-498.95 362.89-498.95approx 453.59 Inert filler magnesium    0-40.82 27.22-40.82 approx 34.02For lubricating stearate properties & to prevent powdered component fromsticking to pill press equipment during compression from powder intosolid tablets croscarmellose    0-22.68 15.88-22.68 approx 18.14 Toreduce sodium water solubility and allow the material to expand,absorbing many times its weight in water and removing much of the waterfrom Berberine.

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

For adults, defined as persons above the age of 12 with a body weightabove 110 pounds, adult's dosage size is two tablets; thereby providingapproximately 100 mg artemisinin per dosage. Tablets must be ingestedthrough the mouth. Directions for taking the anti-chikungunya formulaare as follows:

Day 1—Take two tablets in the morning

-   -   Take two tablets in the evening        Day 2—Take two tablets in the morning    -   Take two tablets in the evening        Day 3—Take two tablets in the morning        Day 4—Take two tablets in the morning

The four-day dosage regimen outlined above as an anti-chikungunyatreatment requires the consumption of a total of 12 tablets over aconsecutive four-day period.

In the tables, a gel cap example can consist of only artemisinin,berberine, capsaicin, and papaya extract in the amounts referenced inthe above tables.

*The blend mixture can consist of a blended mixture approximately 400 mgof concentrate of black walnut (Juglans nigra) dry outer hull;approximately 500 mg of concentrate of organically grown wormwood(Artemisia absinthium) dry flower and leaf; approximately 150 mg ofconcentrate of Clove (Syzygium aronalicum) dry flower; and approximately700 mg of fresh leaf organically grown Chinese wormwood (Artemisiaannua).

The concentrate of black walnut is an astringent that supports theintestinal system. Organically grown wormwood is used to improveappetite, aid in digestive functions, and assist in the absorption ofnutrients. The concentrate of Clove is a carminative, to increasehydrochloric acid in the stomach and to improve peristalsis. Chinesewormwood is used to reduce and stop fever.

The inert ingredients are not therapeutic and are designed for theintegrity, palatability and stability of the tablets. There are manysubstitutes for the various classes of inert ingredients that caninclude disintegrants, lubricants, binders, and excipients. Thefollowing classes can include but are not limited to:

Disintegrants can include but are not limited to guar gums, ion exchangeresins, gums, micro-crystalline cellulose, aginates, cellulose,starches, sodium starch glycolate, cross povidone, gum karaya, chitinand chitosan, smecta, gullan gums, isapghula husk, polacrillanpotassium, and agar.

Lubricants can include but are not limited to stearic acid, magnesiumstearate, silica, hydrogenated vegetable oil, mineral oil, polyethyleneglycol, glyceryl palmitostearate, glyceryl bahenate, sodium benzoate,sodium stearyl fumarate, talc, and silicon dioxide.

Binders can include but are not limited to acacia, alginic acid,aluminum hydroxide, calcium hydroxide, calcium oxide, carboxymethylcellulose, cellulose, ethyl cellulose, gelatin, guar gum, maltodextrin,methyl cellulose, polyethylene glycol, and povidone.

Excipients can include but are not limited to flavorings, cellulosederivatives, calcium carbonate, magnesium stearate, silicon dioxide,masking agents, saccharides and their derivatives, gelatin, syntheticpolymers, coatings and enterics, fillers and stearates.

Dehydrating agents or Desiccating Agents can include but are not limitedto sodium carboxy methyl cellulose, silica gel, microcrystallinecellulose, carboxymethylcellulose calcium, cellulose, colloidal siliconedioxide, and crosscarmellose Sodium.

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin,berberine, capsaicin, and papaya extract in the amounts referenced inthe above tables.

Thus, someone skilled in the art makes a judicious selection of anappropriate dosage regimen; selection is dependent on the age or bodyweight of the patient, condition to be treated and the judiciousselection is not a limitation of the present invention.

Table XIA lists the treatment composition for children in mg per pillfor the treatment of chikungunya (two pills equals dosage).

TABLE XIA Treatment Composition for Children in mg per pill ComponentChildren's Dosing Broad Preferred Preferred Substitution (mg/Pill) RangeRange Amount Category ACTIVE INGREDIENTS artemisinin 12.5-30 mg22.5-27.5 mg approx 25 mg berberine 87.5-250 mg 150-225 mg approx 200 mgCapsaicin 75-150 mg 100-138 mg approx 115 mg Papaya Leaf 20-80 mg 30-50mg approx 60 mg Extract The following ingredients, both inactive andinert, are only used when making a compressed pill INACTIVE INGREDIENTSpeppermint 0-70 mg 35-70 mg approx 50 mg flavoring xylitol 0-1,200 mg800-1,200 mg approx 1,000 mg sweetener 83% maltodextrin & 0-120 mg80-120 mg approx 100 mg Masking agent 17% natural flavors sucralose 0-12mg 8-12 mg approx 10 mg Sweetener. INERT For binding or INGREDIENTSdelivery of other ingredients Silicon dioxide 0-220 mg 160-220 mg approx200 mg Water reducing agent that promotes absorption of water & preventscaking or clumping Calcium 0-1,200 mg 800-1,200 mg approx 1,000 mg Inertfiller carbonate Precipitated silica 0-29 mg 23-29 mg approx 26.66 mgAnticaking free flow agent

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

For children, defined as persons between the ages of 2 and 12 with abody weight below 110 pounds, children's dosage size is two tablets;thereby providing approximately 50 mg artemisinin per dosage. Tabletscan be ingested through the mouth. Directions for taking theanti-chikungunya formula can be as follows:

Day 1—Take two tablets in the morning

-   -   Take two tablets in the evening        Day 2—Take two tablets in the morning    -   Take two tablets in the evening        Day 3—Take two tablets in the morning        Day 4—Take two tablets in the morning

The four-day dosage regimen outlined above as an anti-chikungunyatreatment requires the consumption of a total of 12 tablets over aconsecutive four-day period.

In the tables, a gel cap example can consist of only artemisinin,berberine, capsaicin, and papaya leaf extract in the amounts referencedin the above tables.

The inert ingredients are not therapeutic and are designed for theintegrity, palatability and stability of the tablets. There are manysubstitutes for the various classes of inert ingredients that caninclude disintegrants, lubricants, binders, excipients

Disintegrants can include guar gums, ion exchange resins, gums,micro-crystalline cellulose, aginates, cellulose, starches, sodiumstarch glycolate, cross povidone, gum karaya, chitin and chitosan,smecta, gullan gums, isapghula husk, polacrillan potassium, and agar.

Lubricants can include but are not limited to stearic acid, magnesiumstearate, silica, hydrogenated vegetable oil, mineral oil, polyethyleneglycol, glyceryl palmitostearate, glyceryl bahenate, sodium benzoate,sodium stearyl fumarate, talc, and silicon dioxide.

Binders can include but are not limited to acacia, alginic acid,aluminum hydroxide, calcium hydroxide, calcium oxide, carboxymethylcellulose, cellulose, ethyl cellulose, gelatin, guar gum, maltodextrin,methyl cellulose, polyethylene glycol, and povidone.

Excipients can include but are not limited to flavorings, cellulosederivatives, calcium carbonate, magnesium stearate, silicon dioxide,masking agents, saccharides and their derivatives, gelatin, syntheticpolymers, coatings and enterics, fillers and stearates.

Dehydrating Agents or Desiccating Agents can include but are not limitedto sodium carboxy methyl cellulose, silica gel, microcrystallinecellulose, carboxymethylcellulose calcium, cellulose, colloidal siliconedioxide and crosscarmellose sodium.

Table XIB covers a dose per body weight (in mg per kg) for customizingdosages for children having weights of less than 100 pounds (45.36 kgs)for the treatment of chikungunya:

TABLE XIB DOSE PER BODY WEIGHT FOR CHILDREN (mg per kg) Component BroadPreferred Preferred Range Range Amount Substitution Children's Dosingmg/kg mg/kg mg/kg Category ACTIVE INGREDIENTS artemisinin  5.67-13.6110.21-12.47 approx 11.39 berberine  39.69-113.40  68.04-102.06 approx90.72 Capsaicin 34.09-68.18 45.45-62.73 approx 52.27 Papaya Leaf extract 4.55-18.20  6.82-11.36 approx 13.64 The following ingredients, bothinactive and inert only used when making a compressed pill INACTIVE Forbinding or INGREDIENTS delivery of other ingredients peppermint   0-31.75 15.88-31.75 approx 22.68 flavoring xylitol    0-544.31362.87-544.31 approx 453.60 Sweetener 83% maltodextrin &    0-54.4336.29-54.43 approx 45.36 Masking agent 17% natural flavors sucralose  0-5.44 3.63-5.44 approx 4.54 Sweetener INERT For binding orINGREDIENTS delivery of other ingredients Silicon dioxide    0-99.7972.57-99.79 approx 90.72 Water reducing agent that promotes absorptionof water & prevents caking or clumping Calcium carbonate    0-544.31362.87-544.31 approx 453.60 Inert filler Precipitated silica    0-13.1510.43-13.15 approx 12.09 Anticaking, free flow agent

Approximately is defined as +/−5% in order to cover manufacturingvariances and dosing tolerances.

In the tables, a gel cap example can consist of only artemisinin,berberine, capsaicin, and papaya leaf extract in the amounts referencedin the above tables.

For children, defined as persons between the ages of 2 and 12 with abody weight below 110 pounds, children's dosage size is two tablets;thereby providing approximately 50 mg artemisinin per dosage. Tabletsmust be ingested through the mouth. Directions for taking theanti-chikungunya formula are as follows:

Day 1—Take two tablets in the morning

-   -   Take two tablets in the evening        Day 2—Take two tablets in the morning    -   Take two tablets in the evening        Day 3—Take two tablets in the morning        Day 4—Take two tablets in the morning

The four-day dosage regimen outlined above as an anti-chikungunyatreatment requires the consumption of a total of 12 tablets over aconsecutive four-day period.

Methods of Manufacturing Tablets, Pills and Capsules

Our product by design and claim states a “passively accurate dosingsystem.” Our manufacturing claims stated herein make it extremelypossible to maintain and honor those claims. However, one can neverpreclude the possibility of the existence of some variance when mixingpowdered compounds under high pressure. Although the FDA (stated in a2004 letter from Dr. Steven Galson, then director of the Center for DrugEvaluation and Research at the FDA and now U.S. Surgeon General, that−20/+25%, “actually represents the acceptable bounds on the 90%confidence intervals around the ratio of the mean result for products”)accepts those high deviations as normal, our concern was for tolerancesat those extreme limits. However, while we believe there to be areasonable amount of efficacy and safety at these extremes; we do notexpect to exceed plus or minus 5% of our stated ingredient values.

Before the two active ingredient raw materials are accepted by themanufacturing laboratory, a chemical analysis of the composition isperformed by an independent, third party commercial laboratory. Thisanalysis confirms the purity of the materials as well as other compoundsthat might be present in the shipment. Industry standards for purity andother compounds are known and used to accept or reject a shipment.

Once the product is manufactured but before it is packaged, random batchsamples are sent to another independent, third party commercial analysislaboratory where the pills are inspected and broken down to determinetheir contents. The dosing amounts are maintained as stated on thepackaging, and the pills must be free of any contaminants. Failure toobtain the analysis laboratory approval results in a rejection of thebatch.

In the Examples below, two types of compounds previously identified asanti-malarial agents are combined into one single pill along withcapsaicin and Papaya Leaf extract. Artemisinin is a plant-basedterpenoid compound that is known for use as an anti-malarial agent.Berberine is a plant-based alkaloid with a very bitter taste and watercontent in a range of approximately 14 wt. %. Successful bonding andadhesion through use of non-active ingredients is essential in order toproduce a compressed physically stable pill. Adding granulation steps tothe process reduces water and subsequently reduces the amount ofnon-active ingredients or excipients needed.

In addition, the manufacturing process solves the problem of keeping theformulated pill from becoming hydrated during shipment and storage intropical climates by using blister packing immediately at the end ofprocessing to maintain chemical composition and stability.

While the invention has been described, disclosed, illustrated and shownin various terms of certain embodiments or modifications which it haspresumed in practice, the scope of the invention is not intended to be,nor should it be deemed to be, limited thereby and such othermodifications or embodiments as may be suggested by the teachings hereinare particularly reserved especially as they fall within the breadth andscope of the claims here appended.

I claim:
 1. An artemisinin and berberine treatment composition fortreating a patient in a single pill, tablet or capsule consisting of, incombination: artemisinin; berberine; capsaicin; Papaya Leaf extract; andat least one binding or delivery component, wherein the composition isin a single pill, tablet or capsule, for the treatment of chikungunya.2. The composition of claim 1, wherein the composition is adaptable foran adult patient for the treatment of chikungunya, and consists of:25-60 mg artemisinin; 175-500 mg berberine; 150-300 mg capsaicin; 20-80mg Papaya Leaf extract; and the at least one binding or deliverycomponent, wherein the composition is in a single pill, tablet orcapsule, for the treatment of chikungunya.
 3. The composition of claim2, wherein the composition is adaptable for an adult patient for thetreatment of chikungunya, and consists of: 45-55 mg artemisinin; 400-450mg berberine; 200-275 mg capsaicin; 30-50 mg Papaya Leaf extract; andthe at least one binding or delivery component, wherein the compositionis in a single pill, tablet or capsule, for the treatment ofchikungunya.
 4. The composition of claim 3, wherein the composition isadaptable for an adult patient for the treatment of chikungunya, andconsists of: approximately 50 mg artemisinin; approximately 400 mgberberine; approximately 225 mg capsaicin; and approximately 60 mgPapaya Leaf extract; and the at least one binding or delivery component,wherein the composition is in a single pill, tablet or capsule, for thetreatment of chikungunya.
 5. The composition of claim 2, wherein thecomposition is adaptable for an adult patient for the treatment ofchikungunya, wherein the at least one binding or delivery componentconsists of: at least one ingredient selected from at least one of:microcrystalline cellulose, stearic acid, silicon dioxide, calciumcarbonate, magnesium stearate, and croscarmellose sodium.
 6. Thecomposition of claim 1, wherein the composition is adaptable for anadult patient for the treatment of chikungunya, in mg/kg and consistsof: 22.68-54.43 mg/kg artemisinin; 158.76-453.60 mg/kg berberine;68.18-136.36 mg/kg capsaicin; 9.09-36.36 mg/kg Papaya Leaf extract; andthe at least one binding or delivery component, wherein the compositionis in a single pill, tablet or capsule, for the treatment ofchikungunya.
 7. The composition of claim 6, wherein the composition isadaptable for an adult patient for the treatment of chikungunya, inmg/kg and consists of: 40.82-49.89 mg/kg artemisinin; 272.15-408.23mg/kg berberine; 90.91-125 mg/kg capsaicin; 13.64-22.73 mg/kg PapayaLeaf extract; and the at least one binding or delivery component,wherein the composition is in a single pill, tablet or capsule, for thetreatment of chikungunya.
 8. The composition of claim 7, wherein thecomposition is adaptable for an adult patient for the treatment ofchikungunya, in mg/kg and consists of: approximately 45.36 mg/kgartemisinin; approximately 362.87 mg/kg berberine; approximately 102.27mg/kg capsaicin; approximately 27.27 mg/kg Papaya Leaf extract; and theat least one binding or delivery component, wherein the composition isin a single pill, tablet or capsule, for the treatment of chikungunya.9. The composition of claim 6, wherein the composition is adaptable foran adult patient for the treatment of chikungunya, and the at least onebinding or delivery component consists of: at least one ingredientselected from at least one of: microcrystalline cellulose, stearic acid,silicon dioxide, calcium carbonate, magnesium stearate, andcroscarmellose sodium.
 10. The composition of claim 1, wherein thecomposition is adaptable for a child patient for the treatment ofchikungunya, and consists of: 12.5-30 mg artemisinin; 87.5-250 mgberberine; 75-250 mg capsaicin; 20-80 mg Papaya Leaf extract; and the atleast one binding or delivery component, wherein the composition is in asingle pill, tablet or capsule, for the treatment of chikungunya. 11.The composition of claim 10, wherein the composition is adaptable for achild patient for the treatment of chikungunya, and consists of:22.5-27.5 mg artemisinin; 150-225 mg berberine; 100-138 mg capsaicin;30-50 mg Papaya Leaf extract; and the at least one binding or deliverycomponent, wherein the composition is in a single pill, tablet orcapsule, for the treatment of chikungunya.
 12. The composition of claim11, wherein the composition is adaptable for a child patient for thetreatment of chikungunya, and consists of: approximately 25 mgartemisinin; approximately 200 mg berberine; approximately 115 mgcapsaicin; approximately 60 mg Papaya Leaf extract; and the at least onebinding or delivery component, wherein the composition is in a singlepill, tablet or capsule, for the treatment of chikungunya.
 13. Thecomposition of claim 10, wherein the composition is adaptable for achild patient for the treatment of chikungunya, wherein the at least onebinding or delivery component consists of: at least one ingredientselected from at least one of: peppermint, xylitol, maltodextrin andnatural flavors, and sucralose.
 14. The composition of claim 10, whereinthe composition is adaptable for a child patient for the treatment ofchikungunya, wherein the at least one binding or delivery componentsconsists of: at least one ingredient selected from at least one of:silicon dioxide, calcium carbonate, and precipitated silica.
 15. Thecomposition of claim 1, wherein the composition is adaptable for a childpatient for the treatment of chikungunya in mg/kg, and consists of:5.67-13.61 mg/kg artemisinin; 39.69-113.40 mg/kg berberine; 34.09-68.18mg/kg capsaicin; 4.55-18.20 mg/kg Papaya Leaf extract; and the at leastone binding or delivery component, wherein the composition is in asingle pill, tablet or capsule, for the treatment of chikungunya. 16.The composition of claim 15, wherein the composition is adaptable for achild patient for the treatment of chikungunya in mg/kg, and consistsof: 10.21-12.47 mg/kg artemisinin; 68.04-102.06 mg/kg berberine;45.45-62.73 mg/kg capsaicin; 6.82-11.36 mg/kg Papaya Leaf extract; andthe at least one binding or delivery component, wherein the compositionis in a single pill, tablet or capsule, for the treatment ofchikungunya.
 17. The composition of claim 16, wherein the composition isadaptable for a child patient for the treatment of chikungunya in mg/kg,and consists of: approximately 11.39 mg/kg artemisinin; approximately90.72 mg/kg berberine; approximately 52.27 mg/kg capsaicin;approximately 13.64 mg/kg Papaya Leaf extract; and the at least onebinding or delivery component, wherein the composition is in a singlepill, tablet or capsule, for the treatment of chikungunya.
 18. Thecomposition of claim 15, wherein the composition is adaptable for achild patient for the treatment of chikungunya, wherein the at least onebinding or delivery component consists of: at least one ingredientselected from at least one of: peppermint, xylitol, maltodextrin andnatural flavors, and sucralose.
 19. The composition of claim 15, whereinthe composition is adaptable for a child patient for the treatment ofchikungunya, wherein the at least one binding or delivery componentconsists of: at least one ingredient selected from at least one of:silicon dioxide, calcium carbonate, and precipitated silica.
 20. Anartemisinin and berberine treatment composition consisting of:artemisinin; berberine; capsaicin; Papaya Leaf extract; and at least onebinding or delivery component.